A Study to Investigate the Safety and PK of VH4770359 in Healthy Participants
Recruiting · NCT07525544 · Interventional (participants receive a specific treatment) · Lead sponsor: ViiV Healthcare
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years to 55 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed across 1 US state.
- GSK Investigational Site - Baltimore, Maryland, United States