[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"healthy-participant\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:healthy-participant":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"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":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100604718","phase-1-a-study-to-learn-how-the-study-medicine-called-etrasimod-is-taken-up-into-blood-and-breastmilk-of-healthy-breastfeeding-women-100604718",false,"NCT07153159","A Study to Learn How the Study Medicine Called Etrasimod is Taken up Into Blood and Breastmilk of Healthy Breastfeeding Women","A PHASE 1 MULTIPLE-DOSE, OPEN-LABEL PHARMACOKINETIC STUDY OF ETRASIMOD IN HEALTHY LACTATING WOMEN","Inclusion\n\n1. Healthy (as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs and 12-lead ECGs) lactating women who are actively breastfeeding or expressing breast milk, who are at least 12 weeks post partum and not currently pregnant (must have a negative pregnancy test), and must be 18 to 55 years of age, inclusive, at the time of signing the informed consent document (ICD).\n2. Body mass index (BMI) of 16-35 kg\u002Fm2; and a total body weight \\>45 kg (99 lb).\n3. Participants must be willing to temporarily discontinue breastfeeding their infants for a total of 21 days, ie, from the evening of the day before Day 1 through to 14 days after the last dose (approximately 8 AM the morning of Day 21). Participants must be willing to regularly pump breasts throughout the study and express breast milk according to a schedule designed to maintain lactation until the completion of breast milk collection\n\nExclusion\n\n1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary (such as moderate or severe chronic pulmonary disorders like asthma or chronic obstructive pulmonary disease \\[COPD\\]), gastrointestinal, cardiovascular, hepatic, neurological\u002Fpsychiatric, anaphylactic, ophthalmologic disorders (such as macular edema, uveitis, retinopathy), or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).\n2. Participants with history or presence of second-degree or third-degree atrioventricular (AV) block, sick sinus syndrome, or sinoatrial block.\n3. Resting HR \\\u003C50 bpm at Screening or pre-randomization on Day 1. Measurement can be repeated up to 3 times to confirm the finding. Mean values will be used if repeated.\n4. Recurrent symptomatic bradycardia or recurrent cardiogenic syncope\n5. Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).\n6. Known immunodeficiency disorder, including positive serology for human immunodeficiency virus (HIV), or a first degree relative with a hereditary immunodeficiency, and history of organ transplant (except corneal transplant).\n7. History or evidence of hepatitis B or hepatitis C viruses. Hepatitis B vaccination is allowed.89.\n8. Participants with any of the acute or chronic infections or infection history",true,"FEMALE","18 Years","55 Years",{"count":21,"type":22},8,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This study aims to figure out how much etrasimod, a medication, ends up in breast milk after taking it for several days. To do this, the researchers will work with at least 8 healthy women who are breastfeeding. These women will take a 2 mg dose of etrasimod every day for 7 days while staying at the testing site. During the study, they won't be allowed to breastfeed their babies to keep the babies safe. Instead, they need to have another plan for feeding their babies during this time. The study will look at how the medication is absorbed and how it moves through the body, checking things like the highest level in the blood and how long it takes to reach that level. The researchers will also see how much of the drug is in the breast milk compared to the blood and whether it's safe for the women to take. After the last dose, the women will stay at the site for at least another 24 hours before going home, and follow-up safety calls will be made about 14 and 28 to 35 days later. The whole process from start to finish will take about 10 weeks",[28],"Healthy Participant",[30],"Breast feeding women","RECRUITING","2026-04-01",{"date":34,"type":35},"2026-04-07","ACTUAL",{"date":37,"type":35},"2025-08-07",{"date":39,"type":22},"2026-10-12",{"name":41,"class":42},"Pfizer","INDUSTRY",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":16,"sex":52,"minAge":18,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":5},"100620856","phase-2-a-study-to-evaluate-the-effects-of-the-combination-of-gi-102-with-gib-7-on-biomarkers-of-aging-in-healthy-adults-and-cancer-survivors-100620856","NCT07363057","A Study to Evaluate the Effects of the Combination of GI-102 With GIB-7 on Biomarkers of Aging in Healthy Adults and Cancer Survivors","Phase 2a, Proof-Of-Concept, Multi-National, 8-Week, Randomized, Single-Blinded, Placebo-Controlled Trial of GI-102 in Combination With GIB-7 to Evaluate Its Effects on Biomarkers of Aging in Healthy Adults and Cancer Survivors","GIANTS-1","Key Inclusion Criteria:\n\n1. Must be aged between ≥18 and ≤80 years old at the time of informed consent.\n2. At the discretion of the Investigator, must be in a state of general health that is not severely compromised (ie, no life-threatening illness or disability).\n3. Participants with a history of cancer may be included only if they meet one of the following:\n\n   1. Participants have been disease-free for ≥2 years; OR\n   2. For those diagnosed within 2 years:\n\n      * The cancer was treated with curative intent (eg, surgery, anti-cancer agents including chemotherapy)\n      * Participants have been in remission for ≥12 months\n      * Participants are not on any active cancer treatment except maintenance therapies (eg, endocrine therapy or bisphosphonates)\n      * Participants must have received systemic anti-cancer therapies without immunotherapy for their cancers\n4. Women of childbearing potential (WOCBP; see definition in Section 5.3) must agree to use a highly effective method of contraception from 14 days prior to Visit 2 until 180 days after the last dose of study medication (GI-102 or GIB-7). Fertile men must agree to use an acceptable method of contraception from 14 days prior to Visit 2 until 90 days after the last dose of study medication (GI-102 or GIB-7).\n\nKey Exclusion Criteria:\n\n1. Severe and poorly managed chronic diseases, such as advanced cardiovascular disease, kidney failure requiring transplant or dialysis, uncontrolled diabetes, detectable malignancy (≤ 2 years), severe chronic obstructive pulmonary disease (COPD), or untreatable, terminal cancer as judged by the Investigator or history of life threatening infection (eg, meningitis).\n2. Dependent on walkers or wheelchairs; severe difficulty or inability to perform activities of daily living independently or inability to perform study measures required to test muscle function (an amputee is eligible if participants can walk without walkers or wheelchair) as judged by the Investigator.\n3. Major surgery within the past 6 months or scheduled during the study period, including severe orthopedic diseases requiring joint replacement surgery.\n4. History of substance abuse or dependency or history of recreational IV drug use over the last 5 years (by self-declaration).\n5. Female participants who are pregnant, planning to become pregnant, or breastfeeding during the study period. Participants undergoing perimenopause or the menopause transition are eligible.","ALL","80 Years",{"count":55,"type":22},15,[57],"PHASE2","This Phase 2a clinical study (GIANTS-1) aims to evaluate a novel dual-combination strategy using GI-102 and GIB-7 to address key pathological features of aging, including immunosenescence (the aging of the immune system), metabolic dysfunction, and gut-brain-muscle axis dysregulation.",[60,28,61],"Cancer Survivors","Elderly",[63,64,65,66,67,68],"GI-102","GIB-7","aging","immunosenescence","gut-brain-muscle axis dysregulation","metabolic dysfunction","2026-01-23",{"date":71,"type":35},"2026-01-26",{"date":73,"type":22},"2026-01",{"date":75,"type":22},"2026-10-01",{"name":77,"class":42},"GI Innovation, Inc."]