A Study to Investigate the Safety and PK of VH4770359 in Healthy Participants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: VH4770359, Placebo, Midazolam.
- Who it may be relevant to
- Registry conditions: HIV Infections. Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Multi-part, Phase 1, First-Time-in-Human Study to Investigate Safety, Tolerability, and PK of VH4770359 in Healthy Participants
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.
Interventions
- Drug VH4770359
Participants will receive the assigned dose formulation of VH4770359 orally. - Drug Placebo
Participants will receive placebo to match the VH4770359 dose formulation. - Drug Midazolam
Participants receive 2 mg Midazolam on Days -1, Day 1 and Day 14.
Primary outcome measures
- Number of participants with Grade 3 and Grade 4 adverse events (AEs) [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 outcome measures (2)
- Part A: Area under the curve from time zero extrapolated to infinity (AUC[0-inf]) of VH4770359 following single dose administration [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 [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)]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
- Use of prohibited medications.
- Exclusionary allergies or sensitivities.
- Regular use of alcohol, drugs of abuse, tobacco, or nicotine products.
- Exclusionary prior or concurrent clinical study participation.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- GSK Investigational Site — Baltimore
Identifiers
NCT: NCT07525544 · 300109