[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571411":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":35,"centralContacts":41,"locations":35,"responsibleParty":47,"collaborators":35,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":35,"eligibilityCriteria":55,"healthyVolunteers":56,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":35,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":70,"overallStatus":74,"whyStopped":35,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":35},{"fullName":5,"class":6},"Afasci Inc","INDUSTRY",[8,15,20,24],{"label":9,"type":10,"description":11,"interventionNames":12},"AFA-281 with Ethanol","ACTIVE_COMPARATOR","AFA-281 (40 mg) will be administered as a single dose (oral) in combination with Alcohol (0.6 g\u002Fkg in females or 0.7g\u002Fkg in males).",[13,14],"Drug: AFA-281 is a small molecule, orally available","Other: Alcohol (Ethanol)",{"label":16,"type":17,"description":18,"interventionNames":19},"AFA-281 with Ethanol Placebo","PLACEBO_COMPARATOR","AFA-281 (40 mg) will be administered as a single dose (oral) in combination with the Alcohol placebo (0.6 g\u002Fkg in females or 0.7g\u002Fkg in males).",[13],{"label":21,"type":17,"description":22,"interventionNames":23},"AFA-281 placebo with Ethanol","AFA-281 placebo (40 mg) will be administered as a single dose (oral) in combination with the Alcohol (0.6 g\u002Fkg in females or 0.7g\u002Fkg in males).",[14],{"label":25,"type":26,"description":27,"interventionNames":28},"AFA-281 placebo with Ethanol placebo","SHAM_COMPARATOR","AFA-281 placebo (40 mg) will be administered as a single dose (oral) in combination with the Alcohol placebo (0.6 g\u002Fkg in females or 0.7g\u002Fkg in males).",[13,14],[30,36],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","AFA-281 is a small molecule, orally available","This is a study to evaluate the interaction of AFA-281 with alcohol",[25,9,16],null,{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":35},"OTHER","Alcohol (Ethanol)","Alcohol will be administered in combination with AFA-281 or AFA-281 placebo",[21,25,9],[42],{"name":43,"role":44,"phone":45,"phoneExt":35,"email":46},"Simon Xie, MD","CONTACT","650-995-7320","simonxie@afasci.com",{"type":48,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100571411","phase-1-a-phase-i-study-of-the-interaction-of-alcohol-with-oral-afa-281-in-healthy-volunteers-100571411",false,"NCT06719908","A Phase I Study of the Interaction of Alcohol With Oral AFA-281 in Healthy Volunteers","A Double-blind, Placebo-controlled, Phase I Study of the Pharmacokinetic and Pharmacodynamic Interaction of Oral AFA-281 With Alcohol in Healthy Volunteers","Inclusion Criteria:\n\n* Adults between 21 and 55 years of age, inclusive.\n* Must voluntarily sign and date each informed consent, approved by an Institutional Review Board (IRB), prior to the initiation of any screening or study specific procedures.\n* Currently consumes alcohol regularly (defined as having consumed 7 to 21 standard drinks per week on average in the 6 months prior to screening and having consumed ≥5 standard drinks on at least one occasion in the 30 days prior to screening) but does not meet the DSM-5 criteria for Alcohol Use Disorder. Note: one standard alcoholic drink is equivalent to 1.5 oz. hard liquor or 5 oz. wine or 12 oz. beer.\n* Body mass index (BMI) within the range of 18.5 to 30.0 kg\u002Fm2, inclusive.\n* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG) at the screening visit\n* Adequate venous access\n* Must be surgically sterile (vasectomy, tubal ligation or hysterectomy) or agree to be sexually inactive or agree to use a barrier method of birth control (i.e., condom) from the start of screening until study completion, and agree to refrain from donating sperm, for 90 days after study drug administration.\n* Agree to abstain from strenuous exercise during the inpatient stay of the study.\n\nExclusion Criteria:\n\n* History of significant sensitivity to any drug.\n* Has a clinically significant abnormal ECG or an ECG with a QTc interval corrected for heart rate using the Fridericia formula (QTcF) \\> 430 msec.\n* Has an estimated creatinine clearance (CrCl) outside of normal range.\n* History of head trauma with loss of consciousness, seizures or convulsions, including febrile, alcohol or drug withdrawal seizures.\n* History of gastric surgery, vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption.\n* Requirement for any over-the-counter and\u002For prescription medication, vitamins and\u002For herbal supplements on a regular basis.\n* Use of any medications, vitamins and\u002For herbal supplements within the 2-week period prior to study drug administration.\n* Positive test result for hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (HCV Ab) or HIV antibodies (HIV Ab). Negative HIV status will be confirmed at Screening and the results will be maintained confidentially by the study site.\n* Display any latent signs of alcohol withdrawal per the Clinical Institute Withdrawal of Alcohol Assessment-Revised (CIWA-AR).\n* History or current diagnosis of a substance use disorder.\n* Positive urine drug screen for drugs of abuse at Screening or Day -1.\n* Consumption of alcohol within the 1-day period prior to study drug administration.\n* Receipt of any drug by injection within 30 days prior to study drug administration.\n* History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma), renal, hepatic, gastrointestinal, hematologic, endocrine, dermatological, metabolic or psychiatric disease or disorder, or any uncontrolled medical illness.\n* A clinically notable vital sign abnormality including a history of syncopal or near syncopal events following abrupt change in posture.\n* History of cardiac disease, including family history of long-QT syndrome, second degree heart block Type II, third degree heart block or unexplained sudden deaths in their family.\n* Donation or loss of 550 mL or more blood volume (including plasmapheresis) or receipt of a transfusion of any blood product within 8 weeks prior to study drug administration.\n* Pregnant or nursing women\n* Receipt of any investigational product within 6 weeks prior to study drug administration.\n* Consumption of grapefruit or grapefruit products from 3 days prior to study drug administration.\n* Use of tobacco or nicotine-containing products within the 6-month period preceding study drug administration.\n* Current enrollment in another clinical study.\n* Previous enrollment in this study.\n* Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive AFA-281.",true,"ALL","21 Years","55 Years",{"count":61,"type":62},20,"ESTIMATED","INTERVENTIONAL",[65],"PHASE1","The goal of this clinical trial is to evaluate if alcohol interacts with the drug candidate AFA-281 in adults (healthy volunteers). This trial will evaluate blood concentration levels of AFA-281 and ethanol. The main questions it aims to answer are: Does alcohol interact with AFA-281? What are the side effects (if any)? Researchers will compare AFA-281 to a placebo (a look-alike substance that contains no drug) to see if AFA-281 interacts with alcohol.\n\nParticipants will take a total of 4 treatment sessions separated by at least 2 days between treatments. The treatments will incorporate AFA-281 or placebo with ethanol or ethanol placebo. After each treatment vital signs will be monitored and blood collected to measure AFA-281 and ethanol levels. Participants will provide an assessment survey of symptoms. The total treatment time will be 9 inpatient days (8 nights), and a final follow-up visit 3 to 5 days after clinic discharge.",[68,69],"Alcohol","Alcohol Use Disorders",[71,68,72,73],"AFA-281","Ethanol","Healthy Volunteer","NOT_YET_RECRUITING","2024-12-02",{"date":77,"type":78},"2024-12-06","ACTUAL",{"date":80,"type":62},"2025-07-01",{"date":82,"type":62},"2029-09-01",{"name":5,"class":6}]