[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"drug-drug-interaction\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:drug-drug-interaction":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,42,66,100,128,150,185,207],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100641223","phase-1-a-study-to-learn-about-how-safe-bay3389934-is-and-how-it-affects-blood-clotting-when-given-alone-or-with-aspirin-in-healthy-participants-100641223",false,"NCT07652723","A Study to Learn About How Safe BAY3389934 is and How it Affects Blood Clotting When Given Alone or With Aspirin in Healthy Participants","Open-label, Randomized, Three-fold Cross-over, Drug-drug-interaction Study to Investigate the Influence of Multiple Doses of Acetylsalicylic Acid (ASA) (Aspirin) on the Safety and the Pharmacodynamic Effects of BAY 3389934 in Healthy Participants.","Inclusion Criteria:\n\n* Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.\n* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, vital signs, laboratory tests, and cardiac monitoring.\n* Body mass index within the range 18.0 to 29.9 kg\u002Fm\\^2 (inclusive) at screening visit.\n* Male or female (Women of Non-Childbearing Potential \\[WONCBP\\]) Contraceptive use by participant partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\nMale participants: Participants are eligible to participate if they agree to the following during the study intervention period up to at least 1 day after end of infusion of study intervention to ensure sufficient elimination of BAY3389934 (5 times the elimination half-life of BAY3389934 is approximately 5 hours):\n\n* Refrain from donating sperm\n\nPLUS, either:\n\n* Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR\n* Must agree to use contraception \u002Fbarrier as detailed below:\n\n  * Agree to use a male condom with female partner use of an additional highly effective contraceptive method with a failure rate of \\\u003C 1% per year when having sexual intercourse with a woman of childbearing potential who is not currently pregnant\n  * Agree to use a male condom when engaging in any activity that allows for passage of ejaculate to another person\n\nFemale participants: A female participant is eligible to participate if she is a WONCBP.\n\n* A WONCBP must have a negative highly sensitive pregnancy test (serum) within 24 hours before the first dose of study intervention,\n* The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.\n* Signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n\nExclusion Criteria:\n\n* Medical disorder, condition or history of such that would impair the participant's ability to take part in or complete this study in the opinion of the investigator.\n* Diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study intervention(s) will not be normal.\n* Known hypersensitivity to any study intervention (active substances or excipients of the preparations) to be used in the study - including e.g. non-investigational medicinal products, challenge agents, or rescue medication.\n* Known severe allergies, e.g. allergies affecting the lower respiratory tract - allergic asthma, allergies requiring therapy with corticosteroids, urticaria or significant non-allergic drug reactions.\n* Aspirin hypersensitivity\u002F allergy.\n* Febrile illness within 2 weeks before the start of the first study intervention.\n* Known or suspected liver disorders and bile secretion\u002Fflow (cholestasis, also history of it).\n* History of Morbus Meulengracht (Gilbert´s syndrome) or total bilirubin levels above ULN at screening.\n* History of known or suspected malignant tumors.\n* Tendency to develop keloids or major scars after injuries.\n* Participants experienced surgery (6-months prior to first study intervention), or IM injection (2-week prior to first study intervention).\n* Known disorders with increased bleeding risk (e.g., periodontosis, symptomatic hemorrhoids, acute gastritis, peptic ulcer, vascular malformations and also history of it).\n* Known sensitivity to common causes of bleeding or bruises (e.g., nasal).\n* Known congenital or acquired coagulation disorders (e.g. von Willebrand's disease, hemophilia, platelet dysfunction, etc.).",true,"ALL","18 Years","55 Years",{"count":21,"type":22},16,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","The study treatment BAY3389934 is under development for people with blood clotting problems that occur due to sepsis.\n\nSepsis is a serious condition that happens when the body's reaction to an infection causes organ damage. It can eventually lead to tiny blood clots formation throughout the body.\n\nBAY3389934 aims to work by blocking two important blood clotting proteins, called Factor IIa (thrombin) and Factor Xa, both of which help in blood clotting. By blocking them, BAY3389934 may slow down or stop excessive clotting.\n\nAspirin is a drug that prevents platelets from clumping together. People with sepsis are often given aspirin for underlying heart-related problems. Since aspirin and BAY3389934 both affect how the blood clots, each in a different way, it is important to check whether using them together is safe and whether they change each other's effects on blood clotting.\n\nThe main purpose of this study is to find out how safe BAY3389934 is when given together with aspirin and to see how the two affect blood clotting in healthy participants.\n\nTo do this, the researchers will assess the number and severity of medical problems in healthy adult participants after receiving BAY3389934 alone and in combination with aspirin and compare them with the medical problems when participants received either drug alone.\n\nThese medical problems are also known as \"adverse events\". Doctors keep track of all medical problems that happen in studies, even if they do not think they are related to study treatments.\n\nAll participants will receive a single dose of aspirin tablet prior to the study. Researchers will check their response to decide whether they can participate in the study. Eligible participants will then receive the following three treatments, each at different time and in a different order assigned randomly.\n\nTreatment A:\n\n* no treatment the day prior to receiving study treatment.\n* BAY3389934 as an infusion into a vein on Day 1.\n\nTreatment B:\n\n* a single high-dose aspirin tablet on the day prior to receiving study treatment.\n* a single-low dose aspirin tablet on Day 1.\n\nTreatment C:\n\n* a single high-dose aspirin tablet on the day prior to receiving study treatment.\n* a single low-dose aspirin tablet followed by BAY3389934 4 hours continuous infusion into a vein on Day 1.\n\nThere will be a gap of 3 days after Treatment A, and 14 days after Treatments B and C, when participants will not be given any treatment.\n\nEach participant will be in the study for around 2 months with up to 6 visits to the study clinic. They will visit the study clinic:\n\n* twice, before the treatment starts\n* once, during each of the three treatment periods\n* once, at the end of the treatment\n\nDuring the study, the doctors and their study team will\n\n* check participants' health by performing tests such as blood and urine tests, measuring blood pressure, heart rate and checking heart health using an electrocardiogram (ECG).\n* ask the participants questions about how they are feeling and any adverse events they are having.\n\nIn this study, the participants will not benefit from taking of BAY3389934. However, the study will provide information on how BAY3389934 may be helpful in people with blood clotting problems caused due to sepsis.",[28],"Drug-drug Interaction","RECRUITING","2026-06-11",{"date":32,"type":33},"2026-06-17","ACTUAL",{"date":35,"type":33},"2026-05-29",{"date":37,"type":22},"2026-10-15",{"name":39,"class":40},"Bayer","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":41},"100499893","early-phase-1-interaction-of-cyp2b6-genotype-and-efavirenz-with-methadone-and-tizanidine-pk-100499893","NCT05789173","Interaction of CYP2B6 Genotype and Efavirenz With Methadone and Tizanidine PK","Effect of CYP2B6 Genotype and Efavirenz on the Disposition and Pharmacodynamic of Methadone and Tizanidine in Healthy Volunteers","Inclusion Criteria:\n\nSubjects will be included in the study if participants:\n\n* are male and female (approximately 1:1) volunteers between the age of 18 and 65 years old\n* are judged healthy without any significant medical condition as determined by and decided from a pre-enrollment screening session that include medical history, laboratory tests such as blood and urine tests, vital signs, and an electrical tracing of the heartbeat (electrocardiogram, EKG). The pre-enrollment screening will be done no more than six weeks before the start of the study.\n* are able and willing to adhere to the study medication restrictions two weeks before initiating the study and during the conduct of the entire study. These will include refraining from taking any prescriptions medications, over-the-counter medications, and herbal, dietary, and alternative supplements that may interact with the metabolism of those study drugs at least 2 weeks prior to the start of the study and until study completion.\n* are nonsmoker or individuals willing to refrain from smoking or use of tobacco or marijuana for at least two weeks prior to and until the completion of the study.\n* are willing to commit the time requested for this study.\n\nExclusion Criteria:\n\n* Subjects will be excluded from the study if participants:\n\n  * are underweight (weigh less than 50 kg or 110 lb.) or overweight \\[BMI greater than 32\\]. Body mass index is calculated using height and weight to estimate how much body fat subjects have.\n  * have laboratory results that do not fall in a healthy range\n  * have an electrical tracing (baseline EKG readings) that are abnormal as decided by the study physician (medical doctor).\n  * have history of intolerance, allergic reactions (e.g., rash) or other forms of hypersensitivities to any of the study medications (efavirenz, tizanidine or methadone).\n  * Have a hemoglobin count below the normal range (male \\\u003C13.4 gm\u002FdL: and female \\\u003C12 gm\u002FdL)\n  * have a positive pregnancy urine test (if female) obtained just prior to each study.\n  * are sexually active, who is unable or unwilling to use an appropriate and effective method of birth control (for example barrier methods like diaphragms or condoms) to avoid the possibility of becoming pregnant\n  * are night shift workers in which case taking efavirenz may interfere with their work.\n  * have any significant health condition such heart, liver, or kidney disease\n  * have history or current seizures which may lead to collapse.\n  * have history or current mental illness (brain) such as feeling sad or unhappy, loss of interest in normal activities, worried or suicidality (thoughts about or an unusual preoccupation with ending own life) or suicide attempts.\n  * have gastrointestinal (digestive) disorders such as persistent diarrhea or malabsorption that would interfere with the absorption of orally administered drugs.\n  * have history or current psychiatric disorders such as depression, anxiety, or suicidality or suicide attempts that may be exacerbated by participation in the study\n  * have a history of or current HIV infection or have a lifestyle that places participants at a higher risk for contracting HIV (e.g., drug abuse, excessive alcohol drinking, and having multiple sexual partners).\n  * take more than 2 alcoholic drinks per day on a regular basis for two weeks prior to the study and unwilling to stop alcoholic drinks during the study\n  * unwilling or unable to stop taking drugs of abuse, including tobacco products or marijuana, two weeks prior to and during the entire study period\n  * have a systolic blood pressure lower than 70 mm Hg which may place subjects on high risk for tizanidine induced hypotension\n  * have participated in a research study involving intensive blood sampling or have donated blood within the past two months.\n  * are taking prescription medications, over-the-counter medications, herbal or dietary supplements, and alternative medicines that may interfere with the metabolism of the study drugs (e.g., inhibitors or inducers of CYP2B6 or CYP1A2) and are unable or unwilling to stop taking these medications two weeks prior to and during the entire study period.\n  * are employees or students under supervision of any of the study investigators.\n  * cannot state a good understanding of this study including risks and requirements\n  * are unable to follow the rules of this study.\n  * cannot or unwilling to commit the time requested for this study.","65 Years",{"count":51,"type":22},60,[53],"EARLY_PHASE1","The main goal of this clinical study is to test how CYP2B6 genetic variations and efavirenz (cornerstone in HIV-1 therapy) dictate the disposition (PK) of CYP2B6 substrate (methadone) and PK and effect (PD) of CYP1A2 substrate (tizanidine). Specifically, the investigators will test whether efavirenz produces CYP2B6 genotype dependent unanticipated DDIs with CYP2B6 (methadone) and CYP1A2 (tizanidine), leading to lack of efficacy or increased toxicity. Healthy volunteers genotyped for CYP2B6\\*6 and \\*18 alleles will be grouped in to three genotype predicted phenotype groups: 20 normal metabolizer (NM) (CYP2B6\\*1\u002F\\*1); 20 intermediate metabolizer (IM) (\\*1\u002F\\*6, or \\*1\u002F\\*18); and 20 poor metabolizer (PM) (\\*6\u002F\\*6, \\*6\u002F\\*18 or \\*18\u002F\\*18). Each phenotype group will receive methadone and tizanidine (separated by a washout period) on two occasions: at baseline (control) and after treatment with efavirenz (600 mg\u002Fday for 17 days).",[56],"Drug-Drug Interaction","2026-05-27",{"date":35,"type":33},{"date":60,"type":33},"2023-10-06",{"date":62,"type":22},"2026-12-31",{"name":64,"class":65},"Indiana University","OTHER",{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":16,"sex":74,"minAge":18,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":77,"phases":4,"briefSummary":78,"conditions":79,"keywords":84,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":98,"locationsCount":41},"100632658","pharmacokinetic-study-of-long-acting-antiretrovirals-and-contraceptives-in-hiv-100632658","NCT07516548","Pharmacokinetic Study of Long-acting Antiretrovirals and Contraceptives in HIV","Pharmacokinetic Study of Long-acting Antiretrovirals and Contraceptive Options in HIV Prevention","PHARAOH","Parent Tshireletso Study Inclusion Criteria:\n\n1. Female 18 years of age or older and willing and able to provide an informed consent\n2. \\\u003C 14 days after delivery (calendar day of birth = day 0)\n3. Negative HIV screening test (conducted at the time of enrolment)\n4. Female \\\u003C30 years old or has had \\\u003C 3 prior pregnancies (Gravida 1, 2, or 3 including this pregnancy)\n5. Plan to stay and receive postpartum and pediatric care in the Gaborone or Molepolole region for 24 months\n\nParent Tshireletso Study Exclusion Criteria\n\n1. Receiving carbamazepine, phenobarbital, phenytoin, oxycarbazepine, rifampin, rifabutin, rifapentine, systemic dexamethasone (\\>1 dose oral\u002FIV), or St. John's wort\n2. Suspected to have, recently diagnosed with, or on treatment for TB (due to interaction with rifampicin)\n3. Previous hypersensitivity reaction to CAB or other INSTI\n4. Unstable medical or psychiatric condition making it unlikely they will be able to adhere to injections every 2 months\n5. Plan for pediatric and post-partum care outside the government system (private clinics)\n6. Inflammatory skin condition that compromises the safety of the intramuscular injection\n7. Weight \\\u003C35kg\n\nParent Doris Duke Study Inclusion Criteria Post-partum females included;\n\n1. if HIV-uninfected or unknown HIV status, willing to be tested for HIV\n2. if HIV-infected, documented to be on DTG as part of an antiretroviral treatment regimen\n3. maternal age \\>18 years,\n4. ability to speak English or Setswana\n5. intend to be available for follow up in Molepolole, Gaborone or Mochudi for 18 months post-delivery\n6. have access to a cell phone (including phone of friend or relative)\n\nParent Doris Duke Study Exclusion Criteria Post-partum females excluded if\n\n1. did not attend antenatal care or were not included in Tsepamo surveillance\n2. maternal age \\\u003C18,\n3. females who do not speak English or Setswana,\n4. unable or unwilling to give consent\n5. will not be able to attend follow up at a study site\n6. do not have access to any cell phone for follow up calls\n\nAdditional Inclusion Criteria for this PK Study\n\n1. For DMPA and ETG implant groups, intends to initiate or continue use of DMPA or ETG implant for at least another three or six months, respectively,\n2. For the CAB-LA groups, have received at least three consecutive CAB injections on time, including the one administered concurrently while starting a contraceptive method,\n3. Willing to undergo phlebotomy every 4 weeks for the duration of the sub-study period Additional Exclusion Criteria for this PK Study\n\n1\\) Use or anticipated use of nicotine-containing products (e.g., cigarettes or hookahs) known to interact with CAB-LA for the duration of the sub-study period 2) Use within the previous 90 days, current use, or planned future concomitant use of other hormonal contraceptives, including oral contraceptive methods 3) BMI≥35 4) Has any of the following laboratory abnormalities within the last year:\n\n1. Serum ALT\\>5x ULN at the time of screening,\n2. Serum creatinine \\>2.5x ULN at the time of screening. 5) Has any other condition that, in the opinion of the sub-study PI\u002Fdesignee, would preclude informed consent, make study participation unsafe, or complicate interpretation of study outcome 6) HIV infected females on the Doris Duke parent study","FEMALE",{"count":76,"type":22},105,"OBSERVATIONAL","This study is being done to understand how long-acting injectable cabotegravir (CAB-LA) used for HIV pre-exposure prophylaxis (PrEP) and hormonal contraceptive methods affect each other when used at the same time. Women who are already using CAB-LA or not using PrEP will choose to join one of several groups based on whether they use injectable contraceptive (IM DMPA), an etonogestrel implant, or no hormonal contraceptive. Participants will have study visits every 4 to 12 weeks for up to 12 or 24 weeks after starting a contraceptive method to collect blood samples and measure levels of CAB-LA and hormone concentrations. The study will compare these levels to see if taking CAB-LA changes hormone concentrations or if using hormonal contraception changes CAB-LA drug levels. Safety, side effects, satisfaction, and continuation of CAB-LA PrEP and contraceptive methods will also be evaluated.",[80,81,28,82,83],"HIV Infections","Contraception","PrEP","Long-acting Injectable Cabotegravir for PrEP",[85,86,87,88,89,82,90],"Adolescent girls and young women","Injectable cabotegravir","Botswana","Long-acting injectable cabotegravir","Pharmacokinetic study","HIV prevention","NOT_YET_RECRUITING","2026-05-06",{"date":94,"type":33},"2026-05-08",{"date":96,"type":22},"2026-06-01",{"date":62,"type":22},{"name":99,"class":65},"University of Alabama at Birmingham",{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":16,"sex":74,"minAge":107,"maxAge":108,"enrollmentInfo":109,"targetDuration":4,"studyType":23,"phases":111,"briefSummary":113,"conditions":114,"keywords":115,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":41},"100442713","kuwa-free---live-free-100442713","NCT05044962","Kuwa Free! - Live Free!","Co-benefits of Co-delivery of Long-acting Antiretrovirals and Contraceptives","Inclusion Criteria (PK study):\n\n* Female sex,\n* HIV-positive (for PK groups #1-4) or HIV-uninfected (for PK group #5 only),\n* Age 15-24 years at the time of enrollment,\n* Documented or confirmed viral suppression for HIV (defined as \\\u003C40 copies\u002FmL) within 6 months prior to study enrollment,\n* Have been on the study oral drug for at least 4 weeks for the PK groups #1-4,\n* Have initiated and intends to use DMPA or implant for at least another three or 6 months, respectively,\n* Willing to undergo phlebotomy every 4-12 weeks for the duration of the study period\n* Able to consent or assent (with parental consent) for study participation in English or Kiswahili\n\nExclusion Criteria (PK study):\n\n* Already be on ART that concurrently contains combinations of non-nucleoside reverse transcriptase inhibitors (NNRTIs), such as efavirenz, and protease-inhibitors (PIs), such as atazanavir\u002Fritonavir or lopinavir\u002Fritonavir, or integrase inhibitors (INSTIs), such as raltegravir or dolutegravir\n* Currently pregnant or intends to become pregnant or breastfeeding within the next 12 or 24 weeks for DMPA or implant groups, respectively,\n* Have had unprotected sex in the last two weeks or be currently pregnant via urine pregnancy testing,\n* Use or anticipated use of drugs for the duration of the study period known to interact with hormonal implants or the study ART regimen,\n* Current or planned concomitant use of other hormonal contraceptives,\n* Be obese (BMI≥30),\n* Evidence of Hepatitis B virus (HBV) infection based on the results of testing for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (anti-HBc), Hepatitis B surface antibody (anti-HBs) and HBV Deoxyribonucleic acid (DNA) as follows: positive for HBsAg being excluded or negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA are excluded (of note, participants positive for anti-HBc (negative HBsAg status) and positive for anti-HBs (past and\u002For current evidence) are immune to HBV and are not excluded).\n* Serum ALT\\>5x ULN at the time of screening,\n* Serum creatinine \\>2.5x ULN at the time of screening.\n\nInclusion Criteria Aim 1b (qualitative PK study):\n\n* Participating in PK study for study participants,\n* Self-identifying as provider, program person, policy-maker, or stakeholder relevant to the study topics, and age 18 years of age or older,\n* Able to consent for study participation in English or Kiswahili\n\nInclusion Criteria (Hybrid trial):\n\n* Female sex,\n* HIV-positive,\n* Age 15-24 years at the time of enrollment,\n* Documented or confirmed viral suppression for HIV (defined as \\\u003C40 copies\u002FmL) within 6 months prior to study enrollment,\n* Willing to undergo phlebotomy every 4-12 weeks for the duration of the study period,\n* Able to consent or assent (with parental consent) for study participation in English or Kiswahili\n\nExclusion Criteria (Hybrid trial):\n\n* Already be on ART that concurrently contains combinations of non-nucleoside reverse transcriptase inhibitors (NNRTIs), such as efavirenz, and protease-inhibitors (PIs), such as atazanavir\u002Fritonavir or lopinavir\u002Fritonavir, or integrase inhibitors (INSTIs), such as raltegravir or dolutegravir\n* Currently pregnant or intends to become pregnant or breastfeeding within the next one year,\n* Have had unprotected sex in the last two weeks or be currently pregnant via urine pregnancy testing,\n* Use or anticipated use of drugs for the duration of the study period known to interact with the study ART regimen,\n* Evidence of Hepatitis B virus (HBV) infection based on the results of testing for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (anti-HBc), Hepatitis B surface antibody (anti-HBs) and HBV Deoxyribonucleic acid (DNA) as follows: positive for HBsAg being excluded or negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA are excluded (of note, participants positive for anti-HBc (negative HBsAg status) and positive for anti-HBs (past and\u002For current evidence) are immune to HBV and are not excluded).\n* Serum ALT\\>5x ULN at the time of screening,\n* Serum creatinine \\>2.5x ULN at the time of screening.\n\nInclusion Criteria Aim 2b (qualitative study):\n\n* Participating in hybrid trial study for study participants,\n* Self-identifying as provider, program person, policy-maker, or stakeholder relevant to the study topics, and age 18 years of age or older,\n* Able to consent for study participation in English or Kiswahili","15 Years","24 Years",{"count":110,"type":22},700,[112],"NA","The study investigators are conducting foundational pharmacokinetic (PK) and qualitative studies, among 15-24 years old (inclusive) adolescent girls and young women living with HIV (AGYWLHIV) already on oral antiretroviral therapy (ART) and virally suppressed, leading up to a hybrid type I effectiveness-implementation trial randomizing individual AGYWLHIV to receive long-acting (LA) injectable cabotegravir\u002Frilpivirine vs. standard of care within one of Kenya's largest HIV treatment programs. The PK and qualitative studies will investigate potential issues arising from co-delivery and guide delivery of the effectiveness-implementation trial. The PK and qualitative studies will largely be conducted with a sentinel cohort of AGYWLHIV. Learning from this early LA ART use, the investigators will refine the procedures in the LA ART hybrid trial.",[80,81,28],[116,85,117,118,86,119],"Kenya","HIV adherence","Long-acting antiretroviral therapy","Injectable rilpivirine","2026-04-08",{"date":122,"type":33},"2026-04-13",{"date":124,"type":33},"2021-11-26",{"date":126,"type":22},"2027-03-31",{"name":99,"class":65},{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":135,"enrollmentInfo":136,"targetDuration":4,"studyType":23,"phases":138,"briefSummary":139,"conditions":140,"keywords":4,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":148,"locationsCount":41},"100628509","phase-1-kf20251-trial-ketamine-cannabidiol-and-cobicistat-interaction-study-100628509","NCT07462559","KF2025#1 Trial: Ketamine, Cannabidiol and Cobicistat Interaction Study","KF2025#1","Inclusion Criteria:\n\n* written informed consent\n* age 18-45 years\n* healthy\n* no indications of substance abuse\n* acceptable values in laboratory tests: hemoglobin must be at least at the lower limit of the reference range (men 134 g\u002Fl, women 117 g\u002Fl), liver values at most at the upper limit of the reference range (P -ALAT: women below 35 U\u002Fl, men below 50 U\u002Fl; P -AFOS: 35 U\u002Fl - 105 U\u002Fl; P -GT: women less than 40 U\u002Fl, men less than 60 U\u002Fl; P -Bil: less than 20 umol\u002Fl) and in other results (B -PVKT, P -Krea, P -K and P -Na) only minor values that deviate from normal values, which according to the examining physician's assessment are clinically insignificant. Drug screening (U -Huum-PS) and in women the pregnancy test (P-hCG-tot) should be negative.\n* No significant abnormalities in the ECG\n\nExclusion Criteria:\n\n* significant illness\n* mood disorder or suicidality\n* substance abuse\n* systolic blood pressure over 150 mmHg\n* conduction disorder or other significant abnormality in the ECG\n* smoking\n* regular medication, excluding contraceptives that do not contain estrogens\n* pregnancy or its planning or breastfeeding\n* less than 3 months from the previous clinical trial\n* less than 3 months since donating blood\n* significant overweight or underweight\n* difficult to find elbow veins\n* hypersensitivity to investigational drugs or excipients of medicinal products\n* use of natural products (such as St. John's wort).","45 Years",{"count":137,"type":22},12,[25],"Ketamine is a dissociative anesthetic developed approximately 60 years ago. Both ketamine and its isomer, esketamine, have been used for over 20 years in the treatment of treatment-resistant depression. Other treatment options for this type of depression include combinations of antidepressants, other medications used in depression treatment (such as lithium), psychotherapy, electroconvulsive therapy, and repetitive transcranial magnetic stimulation. The advantage of ketamine and its stereoisomer, esketamine, over other treatment options is their rapidly emerging antidepressant effect, which becomes apparent within the first few days of treatment.\n\nKetamine is primarily metabolized by the cytochrome P450 (CYP) 3A4 enzyme, but also by the CYP2B6 and CYP2C9 enzymes. However, information on the significance of these different enzymes in ketamine metabolism is incomplete. Due to extensive first-pass metabolism, the bioavailability of orally administered ketamine varies significantly and is, on average, only 8-24%. This makes ketamine unsuitable for oral administration. In the treatment of depression, ketamine is administered as a slow intravenous infusion.\n\nThe concurrent use of medications that inhibit ketamine metabolism can significantly increase the bioavailability of orally administered ketamine. Cobicistat is a potent inhibitor of the CYP3A4 enzyme, which can significantly increase ketamine bioavailability and reduce interindividual variability by inhibiting ketamine's CYP3A4-mediated metabolism. This might enable the oral use of ketamine.\n\nCannabidiol is a cannabinoid that does not have addictive effects, but may have antidepressant and anxiolytic effects. Cannabidiol might reduce the dissociative side effects associated with ketamine treatment. Clinically, cannabidiol appears to moderately inhibit CYP enzymes in the order of potency: CYP2C19 \\> CYP2C9 \\> CYP3A \\> CYP1A2, and based on in vitro data, it also somewhat inhibits the CYP2B6 enzyme, which is involved in ketamine metabolism. However, its effect on ketamine concentrations cannot be assessed based on current knowledge.\n\nThe purpose of this study is to investigate the potential effects of cannabidiol, cobicistat, and their concurrent administration on the pharmacokinetics of orally administered ketamine. A secondary objective is to study the effect of cannabidiol on ketamine-induced side effects.\n\nStudy Methodology: This is a four-phase, randomized, open-label, crossover study involving 12 healthy volunteers. On study days, participants will receive a 56 mg oral dose of ketamine in the research facility, alternately with water, cannabidiol, cobicistat, or both cannabidiol and cobicistat. There will be at least a two-week washout period between study days.\n\nThe pharmacokinetics of ketamine and other study drugs will be investigated by taking blood samples according to a separate schedule for 11 hours after administration on the study day and the following morning. Pharmacokinetic parameters will be calculated from plasma concentrations of ketamine, cobicistat, cannabidiol, and their metabolites. The primary outcome measure is the total area under the curve (AUC0-∞) of ketamine. Additionally, the effects of the drugs on blood pressure, heart rate, and subjective adverse feeling of the study participants will be examined.",[141],"Drug Drug Interaction","2026-03-05",{"date":144,"type":33},"2026-03-10",{"date":146,"type":22},"2026-03-04",{"date":62,"type":22},{"name":149,"class":65},"Helsinki University Central Hospital",{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":156,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":17,"minAge":158,"maxAge":4,"enrollmentInfo":159,"targetDuration":4,"studyType":77,"phases":4,"briefSummary":161,"conditions":162,"keywords":167,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":41},"100614652","association-between-geriatric-frailty-and-medication-related-problems-in-the-emergency-department-to-help-clinical-pharmacists-prioritise-patients-100614652","NCT07282379","Association Between Geriatric Frailty and Medication Related Problems in the Emergency Department to Help Clinical Pharmacists Prioritise Patients","DETECTION OF ISAR-FLAGGED AT-RISK MEDICATION IN THE EMERGENCY DEPARTMENT (DISARMED)","DISARMED","Inclusion Criteria:\n\n* Patients aged ≥ 75 years admitted to the adult emergency department\n* Patients able to give informed consent as documented by signature or a therapeutic representative, if applicable .\n\nExclusion Criteria:\n\n* Patients initially admitted to the emergency resuscitation room.\n* Patients admitted to the minor accidents and emergencies room.\n* Patients admitted to the stroke unit, as they just pass through the emergency department to directly proceed to the CT-scanner.\n* Missing data for proper file analysis (e.g., missing usual home medication)\n* Patient's inability to sign consent and no therapeutic representative available\n* Patient's refusal to sign consent\n* Emergency physician's refusal to include patient for any reason.","75 Years",{"count":160,"type":22},300,"The healthcare systems are under increasing pressure due to a rise in emergency consultations, staff shortages, an ageing population and rising costs. Emergency departments are seeing more vulnerable patients, including elderly people, who are often on multiple medications and at risk of medication errors.\n\nTo improve safety, the integration of pharmacists specialising in emergency medicine has proven beneficial: their presence in the team improves the detection of medication-related problems, speeds up and optimises treatment, reduces rehospitalisations and lowers healthcare costs. However, in most countries, these pharmacists are still rarely found in emergency departments, mainly due to a lack of resources and clinical prioritisation criteria tailored for them and adapted to this environment.\n\nFrailty screening tools and scores, such as ISAR, can be used to identify the elderly patients most at risk, predict adverse events such as fall or mortality, and thus adapt their care in the emergency department. Indeed, elderly frail patients often take many medications and consequently are at risk of medication errors, adverse events, inappropriate prescriptions or serious drug interactions. These patients may therefore require a specialised review on their medication by clinical pharmacists when they are admitted to the emergency department, but their high number make it impossible to care for all of them.\n\nWe aim thus to evaluate the association between frailty (according to the ISAR score) and medication-related problems among elderly patients admitted to the emergency department. Researchers will examine whether this score can predict the presence of inappropriate prescribing and high-risk drug interactions. If so, pharmacists would then have a quick and easy tool to prioritise patients who would benefit most from a specialised review of their medications when they visit the emergency department.\n\nThere will not be any intervention and this study will not influence patients care. Once patients agree to participate, researchers will prospectively collect medical data from elderly patients admitted to the emergency department and analyse their medical history, home medication, reason for admission, frailty score using ISAR, and perform a pharmaceutical analysis based on these data.",[163,164,165,141,166],"Frailty","Emergency Department Visit","Elderly","Inappropriate Drug Use",[168,169,170,171,172,173,174,175],"emergency department","clinical pharmacists","elderly","frailty","ISAR","inappropriate prescription","Drug interaction","drug-related problems","2025-12-02",{"date":178,"type":33},"2025-12-15",{"date":180,"type":22},"2026-03-01",{"date":182,"type":22},"2026-09",{"name":184,"class":65},"Pharmacie des Hopitaux de l'Est Lemanique",{"id":186,"slug":187,"hasResults":11,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":4,"eligibilityCriteria":191,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":192,"targetDuration":4,"studyType":77,"phases":4,"briefSummary":194,"conditions":195,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":206},"100568522","pharmaco-proteomic-platform-to-evaluate-drug-interactions-in-liver-transplant-patients-100568522","NCT06682325","Pharmaco-proteomic Platform to Evaluate Drug Interactions in Liver Transplant Patients","Development of a Pharmaco-proteomic Platform to Evaluate Potential Drug Interactions and Their Clinical Impact in Liver Transplant Patients Undergoing Multidrug Treatment","Inclusion Criteria:\n\n* Liver transplant patients undergoing surgery at UC Christus Hospital\n\nExclusion Criteria:\n\n* Patients on renal replacement therapy\n* Patients for whom no clinical or pharmacological registry is available",{"count":193,"type":22},48,"The goal of this observational study is to enhance the ability to forecast kidney failure in liver transplant patients in the ICU under multidrug treatment by developing a computer platform that integrates mathematical models of drug interactions, proteomics, and clinical data. The main outcomes it aims to develop are:\n\n1. Design the multidrug web computing platform with available information on drug pair interactions (DDIs).\n2. Integrate the proteomic and clinical data of liver transplant patients into the IT platform.\n3. Implement the multidrug web platform to predict the clinical evolution of liver transplant patients.",[28,196],"Liver Transplantation","2024-11-07",{"date":199,"type":33},"2024-11-12",{"date":201,"type":33},"2023-06-01",{"date":203,"type":22},"2025-05-05",{"name":205,"class":65},"Pontificia Universidad Catolica de Chile",3,{"id":208,"slug":209,"hasResults":11,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":4,"eligibilityCriteria":213,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":214,"targetDuration":4,"studyType":77,"phases":4,"briefSummary":216,"conditions":217,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":41},"100545397","drug-drug-interactions-with-anti-tuberculous-drugs-100545397","NCT06381375","Drug-drug Interactions With Anti-tuberculous Drugs","Assessment of the Prevalence and the Outcome of Prescribing Drugs Known to Have Major Drug-Drug Interactions With Anti-tuberculous Drugs Among Kasr Alainy Tuberculous Patients","Inclusion Criteria:\n\n* All patients diagnosed with tuberculosis and referred to Tuberculosis outpatient clinic, Kasr Alainy Faculty of Medicine, Cairo University, starting after the obtaining of the Scientific\u002FEthical approval of the study protocol.\n\nExclusion Criteria:\n\n* Refusal by the patient\u002Fpatient's guardian to participate in this study",{"count":215,"type":22},400,"This study aims to assess the prevalence and the outcome of prescribing drugs known to have major drug-drug interactions with anti-tuberculous drugs among Kasr Alainy tuberculous patients.",[28],"2024-08-20",{"date":220,"type":33},"2024-08-22",{"date":222,"type":33},"2024-04-30",{"date":224,"type":22},"2025-02-15",{"name":226,"class":65},"Cairo University"]