Health TrialsbyHealthPanel

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

ConditionHIV Infections
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorViiV Healthcare

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

18 to 55 years old

BMI 18.5-37.0 kg/m2

Male participants must adhere to contraception requirements or abstinence, and female participants must not be pregnant/breastfeeding and be of non-childbearing potential.

Disqualifiers

Participants with significant medical history that could alter drug pharmacokinetics, pose a risk, or interfere with conduct.

Has exclusionary psychiatric, hepatic, cardiovascular, gastrointestinal, respiratory, endocrine, neurological, hematological, or renal condition, or exclusionary malignancy.

A positive test(s) for Hepatitis B surface antigen (HBsAg) and/or anti-HBc, hepatitis C antibodies, or human immunodeficiency virus (HIV).

A history of or ongoing high-risk behaviors for HIV acquisition.

Trial design

Design model

Sequential

Treatments tested in this trial

  • VH4770359

    Drug

    Participants will receive the assigned dose formulation of VH4770359 orally.

  • Placebo

    Drug

    Participants will receive placebo to match the VH4770359 dose formulation.

  • Midazolam

    Drug

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

Treatment groups

214 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Part A: VH4770359 SAD groupExperimental treatment 1 intervention
Group B: Part A: Placebo SAD groupPlacebo comparator 1 intervention
Group C: Part B: VH4770359 MAD groupExperimental treatment 1 intervention
Group D: Part B: Placebo MAD groupPlacebo comparator 1 intervention
Group E: Part B: VH4770359 MAD Drug-Drug Interaction (DDI) groupExperimental treatment 2 interventions
Group F: Part B: Placebo MAD DDI groupPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

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

1

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)
2

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ViiV Healthcare

Lead sponsor

Source ClinicalTrials.gov
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