First-Time-in-Human (FTIH) Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of VH4004280 in Healthy Participants
- Registration Number
- NCT05163522
- Lead Sponsor
- ViiV Healthcare
- Brief Summary
This FTIH study aims to evaluate the safety, tolerability and PK of the novel investigational Human immunodeficiency virus (HIV)-1 capsid inhibitor VH4004280 in healthy adults. The study will be conducted in 3 parts: Part 1 will investigate single ascending doses (SAD), Part 2 will investigate multiple ascending doses and drug-drug interaction (MAD/MAD DDI) Part 3 will investigate single dose relative bioavailability (RBA) of a new formulation of VH4004280.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 73
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 1 (SAD): Participants receiving VH4004280 VH4004280 - Part 1 (SAD): Participants receiving placebo Placebo - Part 2 (MAD) Non Drug-Drug Interaction (DDI) cohort: Participants receiving VH4004280 VH4004280 - Part 2 (MAD) Non DDI cohort: Participants receiving placebo Placebo - Part 2 (MAD) DDI cohort: Participants receiving VH4004280 and Midazolam VH4004280 - Part 2 (MAD) DDI cohort: Participants receiving Placebo and Midazolam Placebo - Part 3 (Single dose): Participants receiving VH4004280 (new formulation) VH4004280 - Part 2 (MAD) DDI cohort: Participants receiving VH4004280 and Midazolam Midazolam - Part 2 (MAD) DDI cohort: Participants receiving Placebo and Midazolam Midazolam -
- Primary Outcome Measures
Name Time Method Part 1: Absolute values of liver panel parameters: Alanine aminotransferase (ALT), Alkaline phosphatase (ALP) and Aspartate aminotransferase (AST) (International units per Liter) Up to Day 49 Part 2: Percentage of participants with maximum toxicity grade increase from Baseline for liver panel parameters Up to Day 63 Part 1: Number of participants with AEs by severity Up to Day 49 Part 2: Absolute values of liver panel parameters: Direct and total bilirubin (Micromoles per liter) Up to Day 63 Part 2: Absolute values of liver panel parameters: ALT, ALP and AST (International units per Liter) Up to Day 63 Part 3: Absolute values of liver panel parameters: Direct and total bilirubin (Micromoles per liter) Up to Day 49 Part 1: Change from Baseline in liver panel parameters: Direct and total bilirubin (Micromoles per liter) Baseline and up to Day 49 Part 1: Change from Baseline in liver panel parameters: ALT, ALP and AST (International units per Liter) Baseline and up to Day 49 Part 3: Change from Baseline in liver panel parameters: Direct and total bilirubin (Micromoles per liter) Baseline and up to Day 49 Part 1: Percentage of participants with maximum toxicity grade increase from Baseline for liver panel parameters Up to Day 49 Part 1: Area under the plasma concentration time curve from time zero to infinity (AUC[0-infinity]) following single dose administration of VH4004280 Up to Day 49 Part 1: Number of participants with adverse events (AEs) Up to Day 49 Part 2: Number of participants with AEs Up to Day 63 Part 3: Number of participants with AEs Up to Day 49 Part 2: Number of participants with AEs by severity Up to Day 63 Part 3: Number of participants with AEs by severity Up to Day 49 Part 2: Percentage of participants discontinuing treatment due to AEs Up to Day 14 Part 2: Change from Baseline in liver panel parameters: Direct and total bilirubin (Micromoles per liter) Baseline and up to Day 63 Part 1: Absolute values of liver panel parameters: Direct and total bilirubin (Micromoles per liter) Up to Day 49 Part 2: Area under the plasma concentration time curve over a dosing interval from time of dosing to the time of the subsequent dose (AUC[0-tau]) following repeat dose administration of VH4004280 Up to Day 63 Part 3: Absolute values of liver panel parameters: ALT, ALP and AST (International units per Liter) Up to Day 49 Part 2: Change from Baseline in liver panel parameters: ALT, ALP and AST (International units per Liter) Baseline and up to Day 63 Part 3: Change from Baseline in liver panel parameters: ALT, ALP and AST (International units per Liter) Baseline and up to Day 49 Part 3: Percentage of participants with maximum toxicity grade increase from Baseline for liver panel parameters Up to Day 49 Part 1: Maximum observed plasma concentration (Cmax) following single dose administration of VH4004280 Up to Day 49 Part 1: Time to maximum observed plasma concentration (Tmax) and Apparent terminal half-life (T1/2) following single dose administration of VH4004280 (Hours) Up to Day 49 Part 2: Cmax following repeat dose administration of VH4004280 Up to Day 63 Part 2: Tmax and T1/2 following repeat dose administration of VH4004280 (Hours) Up to Day 63
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
GSK Investigational Site
🇺🇸Las Vegas, Nevada, United States