A Study to Investigate the Safety and PK of VH4770359 in Healthy Participants

Phase 1RecruitingNCT07525544

ViiV Healthcare214 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

214

Conditions

HIV Infections

Interventions

VH4770359DRUG

Participants will receive the assigned dose formulation of VH4770359 orally.

PlaceboDRUG

Participants will receive placebo to match the VH4770359 dose formulation.

MidazolamDRUG

Participants receive 2 mg Midazolam on Days -1, Day 1 and Day 14.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. 18 to 55 years old 2. BMI 18.5-37.0 kg/m2 3. Male participants must adhere to contraception requirements or abstinence, and female participants must not be pregnant/breastfeeding and be of non-childbearing potential. Exclusion Criteria: 1. Participants with significant medical history that could alter drug pharmacokinetics, pose a risk, or interfere with conduct. 2. Has exclusionary psychiatric, hepatic, cardiovascular, gastrointestinal, respiratory, endocrine, neurological, hematological, or renal condition, or exclusionary malignancy. 3. A positive test(s) for Hepatitis B surface antigen (HBsAg) and/or anti-HBc, hepatitis C antibodies, or human immunodeficiency virus (HIV). 4. A history of or ongoing high-risk behaviors for HIV acquisition. 5. Use of prohibited medications. 6. Exclusionary allergies or sensitivities. 7. Regular use of alcohol, drugs of abuse, tobacco, or nicotine products. 8. Exclusionary prior or concurrent clinical study participation.

Locations (1)

GSK Investigational Site

Baltimore, Maryland, United States

RECRUITING

Outcomes

Primary Outcomes

Number of participants with Grade 3 and Grade 4 adverse events (AEs)

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The AEs are graded using the Division of Acquired Immunodeficiency Syndrome (DAIDS) criteria where grades are defined based on numeric criteria as follows Grade 3: severe symptoms; Grade 4: potentially life-threatening. A higher grade indicates greater severity.

Time frame: From Day 1 (first dose of study intervention) in each treatment period until the last on-site study visit (up to approximately 9 weeks)

Secondary Outcomes

Part A: Area under the curve from time zero extrapolated to infinity (AUC[0-inf]) of VH4770359 following single dose administration

AUC(0-inf) is calculated using a standard non-compartmental analysis.

Time frame: At Day 1 (pre-dose, 0.5h 1h, 2h, 3h, 4h, 6h, 8h,12h), Day 2 (24h, 36h), Day 3, Day 4, Day 5, Day 6, Day 7 and during outpatient visits until the last on site study visit (up to approximately 9 weeks)

Part B: AUC over a single dosing interval from time 0 to the next dose (AUC[0-tau]) of VH4770359 following multiple dose administration

AUC(0-tau) is calculated using a standard non-compartmental analysis.

Time frame: At Day 1 (pre-dose, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h) and at Day 14 (pre-dose, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h)

Central Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

Data from ClinicalTrials.gov

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