HIV Infections
Conditions
Keywords
First-Time-in-Human, Safety, Tolerability, Pharmacokinetics, Healthy participants, Human immunodeficiency virus (HIV), VH4770359 (GSK4770359), Oral
Brief summary
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
DRUGVH4770359
Participants will receive the assigned dose formulation of VH4770359 orally.
DRUGPlacebo
Participants will receive placebo to match the VH4770359 dose formulation.
DRUGMidazolam
Participants receive 2 mg Midazolam on Days -1, Day 1 and Day 14.
Sponsors
ViiV Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Double-blind.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with Grade 3 and Grade 4 adverse events (AEs) | From Day 1 (first dose of study intervention) in each treatment period until the last on-site study visit (up to approximately 9 weeks) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part A: Area under the curve from time zero extrapolated to infinity (AUC[0-inf]) of VH4770359 following single dose administration | 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) | AUC(0-inf) is calculated using a standard non-compartmental analysis. |
| Part B: AUC over a single dosing interval from time 0 to the next dose (AUC[0-tau]) of VH4770359 following multiple dose administration | 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) | AUC(0-tau) is calculated using a standard non-compartmental analysis. |
Countries
United States
Contacts
CONTACTUS GSK Clinical Trials Call Center
CONTACTEU GSK Clinical Trials Call Center
Outcome results
None listed