[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100053226":3},{"organization":4,"armGroups":7,"interventions":37,"overallOfficials":43,"centralContacts":52,"locations":61,"responsibleParty":84,"collaborators":43,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":43,"eligibilityCriteria":92,"healthyVolunteers":93,"sex":94,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":43,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":106,"overallStatus":64,"whyStopped":43,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"ViiV Healthcare","INDUSTRY",[8,14,20,24,28,33],{"label":9,"type":10,"description":11,"interventionNames":12},"Part A: VH4770359 SAD group","EXPERIMENTAL","Healthy participants will receive a single dose of VH4770359 on Day 1. Up to 7 cohorts will receive single ascending doses (SAD).",[13],"Drug: VH4770359",{"label":15,"type":16,"description":17,"interventionNames":18},"Part A: Placebo SAD group","PLACEBO_COMPARATOR","Healthy participants will receive a single dose of Placebo on Day 1.",[19],"Drug: Placebo",{"label":21,"type":10,"description":22,"interventionNames":23},"Part B: VH4770359 MAD group","Healthy participants will receive 14 daily repeat doses of VH4770359 from Day 1 to Day 14. Up to 4 cohorts will receive multiple ascending doses (MAD).",[13],{"label":25,"type":16,"description":26,"interventionNames":27},"Part B: Placebo MAD group","Healthy participants will receive 14 daily repeat doses of Placebo from Day 1 to Day 14.",[19],{"label":29,"type":10,"description":30,"interventionNames":31},"Part B: VH4770359 MAD Drug-Drug Interaction (DDI) group","Healthy participants will receive 14 daily repeat doses of VH4770359 from Day 1 to Day 14. Participants will also receive 2 mg Midazolam on Days -1, Day 1 and Day 14.",[13,32],"Drug: Midazolam",{"label":34,"type":16,"description":35,"interventionNames":36},"Part B: Placebo MAD DDI group","Healthy participants will receive 14 daily repeat doses of Placebo from Day 1 to Day 14. Participants will also receive 2 mg Midazolam on Days -1, Day 1 and Day 14.",[19,32],[38,44,48],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"DRUG","VH4770359","Participants will receive the assigned dose formulation of VH4770359 orally.",[9,29,21],null,{"type":39,"name":45,"description":46,"armGroupLabels":47,"otherNames":43},"Placebo","Participants will receive placebo to match the VH4770359 dose formulation.",[15,34,25],{"type":39,"name":49,"description":50,"armGroupLabels":51,"otherNames":43},"Midazolam","Participants receive 2 mg Midazolam on Days -1, Day 1 and Day 14.",[34,29],[53,58],{"name":54,"role":55,"phone":56,"phoneExt":43,"email":57},"US GSK Clinical Trials Call Center","CONTACT","877-379-3718","GSKClinicalSupportHD@gsk.com",{"name":59,"role":55,"phone":60,"phoneExt":43,"email":57},"EU GSK Clinical Trials Call Center","+44 (0) 20 89904466",[62],{"facility":63,"status":64,"city":65,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"GSK Investigational Site","RECRUITING","Baltimore","Maryland","21225","United States","US",{"type":71,"coordinates":72},"Point",[73,74],-76.61219,39.29038,{"lat":74,"lon":73},[77,78,81],{"name":54,"role":55,"phone":56,"phoneExt":43,"email":57},{"name":79,"role":55,"phone":80,"phoneExt":43,"email":57},"EU GSK Clinical Trials Call Centre","+44 (0) 20 8990 4466",{"name":82,"role":83,"phone":43,"phoneExt":43,"email":43},"Ronald Goldwater","PRINCIPAL_INVESTIGATOR",{"type":85,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR","100053226","phase-1-a-study-to-investigate-the-safety-and-pk-of-vh4770359-in-healthy-participants-100053226",false,"NCT07525544","A Study to Investigate the Safety and PK of VH4770359 in Healthy Participants","A Multi-part, Phase 1, First-Time-in-Human Study to Investigate Safety, Tolerability, and PK of VH4770359 in Healthy Participants","Inclusion Criteria:\n\n1. 18 to 55 years old\n2. BMI 18.5-37.0 kg\u002Fm2\n3. Male participants must adhere to contraception requirements or abstinence, and female participants must not be pregnant\u002Fbreastfeeding and be of non-childbearing potential.\n\nExclusion Criteria:\n\n1. Participants with significant medical history that could alter drug pharmacokinetics, pose a risk, or interfere with conduct.\n2. Has exclusionary psychiatric, hepatic, cardiovascular, gastrointestinal, respiratory, endocrine, neurological, hematological, or renal condition, or exclusionary malignancy.\n3. A positive test(s) for Hepatitis B surface antigen (HBsAg) and\u002For anti-HBc, hepatitis C antibodies, or human immunodeficiency virus (HIV).\n4. A history of or ongoing high-risk behaviors for HIV acquisition.\n5. Use of prohibited medications.\n6. Exclusionary allergies or sensitivities.\n7. Regular use of alcohol, drugs of abuse, tobacco, or nicotine products.\n8. Exclusionary prior or concurrent clinical study participation.",true,"ALL","18 Years","55 Years",{"count":98,"type":99},214,"ESTIMATED","INTERVENTIONAL",[102],"PHASE1","VH4770359 (also known as GSK4770359) is an antiretroviral compound. This first-in-human study aims to evaluate the safety, tolerability, and pharmacokinetics (PK) of orally administered VH4770359 in healthy participants. The findings from this study will support the design of future clinical studies of VH4770359 in people living with HIV.",[105],"HIV Infections",[107,108,109,110,111,112,113,114],"First-Time-in-Human","Safety","Tolerability","Pharmacokinetics","Healthy participants","Human immunodeficiency virus (HIV)","VH4770359 (GSK4770359)","Oral","2026-07-10",{"date":117,"type":118},"2026-07-13","ACTUAL",{"date":120,"type":118},"2026-05-14",{"date":122,"type":99},"2027-05-05",{"name":5,"class":6},1]