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WITHDRAWNPHASE1

VH3739937 Phase 1 Multiple Ascending Dose (MAD) Study in Healthy Volunteers Including Relative Bioavailability (RBA), Optional Food Effect (FE), and Drug-drug Interaction (DDI)

A Multi-part Phase 1 Study Assessing the Safety, Tolerability, and PK of VH3739937 in Healthy Participants, by Conducting MAD and RBA Cohorts, With Optional Food Effect and Drug Interaction Cohorts

NCT06533280•ViiV Healthcare

View on ClinicalTrials.gov

Summary

This study will assess safety, tolerability and pharmacokinetic (PK) of VH3739937 in healthy participants.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Participants who are overtly healthy as determined by the Investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring (history and ECG).
•2. Participants who can understand and comply with protocol requirements and timetables, instructions, and protocol-stated restrictions.
•Age
•3. Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
•Weight
•4. Body weight \>=50.0 kg (110 lbs) for men and \>=45.0 kg (99 lbs) for women, and BMI within the range 18.5 to 32.0 kg/m2 (inclusive).
•Sex
•5. Participants male at birth and participants female at birth:
•1. Participants male at birth:
•Participants male at birth are eligible to participate if they agree to the following during the study intervention period and for at least 90 days (a spermatogenesis cycle) after the last dose of study intervention:
+11 more criteria

Exclusion Criteria

•Medical conditions
•1. History or presence of cardiovascular, respiratory, hepatic, renal, GI, endocrine, hematologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data.
•2. Unstable liver disease known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per Investigator assessment).
•3. Known history of cirrhosis with or without viral hepatitis co-infection.
•4. History of clinically relevant hepatitis within last 6 months.
•5. Patients with chronic hepatitis B (HBsAg positive) infection (see HBV diagnostic criteria described below and in the study laboratory manual).
•6. Have a history of malignant neoplasm (excepting definitively treated non-melanoma skin cancer or carcinoma in situ of the uterine cervix, which may be enrolled at any time) within the last 5 years.
•7. Clinically significant cardiovascular disease.
•8. A sustained semi-supine systolic blood pressure \>150 mm Hg or \<90 mm Hg or a semi-supine diastolic blood pressure \>95 mm Hg or \<50 mm Hg at Screening or Check-in.
•9. A resting HR of \<50 bpm or \>100 bpm when vital signs are measured at Screening or Check-in. A HR from 100 bpm to 110 bpm can be rechecked by ECG or vital signs within up to 2 hours to verify eligibility.
+34 more criteria

Locations (1)

GSK Investigational Site

Baltimore, Maryland, United States

Key Dates

Start Date

August 2, 2024

Primary Completion Date

August 14, 2024

Completion Date

August 14, 2024

Last Updated

April 22, 2025

Conditions

HIV Infections

Interventions

Part A, C and D: VH3739937 500 mg

DRUG

Part A: VH3739937 100 mg

DRUG

Part A and C: Placebo

DRUG

Part B: Treatment A

DRUG

Part B: Treatment B

DRUG

Part B: Treatment C

DRUG

Part B: Treatment D

DRUG

Part B: Treatment E

DRUG

Part D: Probe cocktail

DRUG

Skeletal Muscle Energetics and Fatiguability in Older Individuals

NCT04142047

HIVHIV Infections

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RECRUITINGPHASE3

A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1

NCT06694805

HIV Infections

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 22, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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VH3739937 Phase 1 Multiple Ascending Dose (MAD) Study in Healthy Volunteers Including Relative Bioavailability (RBA), Optional Food Effect (FE), and Drug-drug Interaction (DDI)

Inclusion Criteria

Exclusion Criteria

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