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

Phase
Recruitment status
Participants
Lead sponsor
ViiV Healthcare
Start date
Number of sites

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.
Short title
A Study to Investigate the Safety and PK of VH4770359 in Healthy Participants
Official title
A Multi-part, Phase 1, First-Time-in-Human Study to Investigate Safety, Tolerability, and PK of VH4770359 in Healthy Participants

Control arm
Registry reports results
Listing at source
Recruitment status
Phase
Study type
Interventional

Completion date
First posted
Registry last updated
Primary completion date
Start date

Participants
Participant count basis
Planned participants
Protocol amendments
Number of sites

Data monitoring committee
Registry sponsor category
Lead sponsor
ViiV Healthcare
Source registry
ClinicalTrials.gov

Registry ID
ClinicalTrials.gov ID
Registry record
Open registry record

Allocation
Randomised
Model
Sequential
Purpose
Treatment
Masking
Triple masking
Masking description
Double-blind.
Masked roles
Participants, Care providers, Investigators
Sources for study design

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

    Timeframe: 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.

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

    Timeframe: 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.

  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

    Timeframe: 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.

Sources for outcomes

Sex
All
Age groups
Adults
Minimum age
18 Years
Maximum age
55 Years
Healthy volunteers
Yes

  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.

  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.
Sources for eligibility

  • GSK Investigational SiteBaltimore, United StatesRecruiting
Sources for sites

Related records

Drugs (1)

Lead sponsors (1)

Conditions (2)

Targets (16)