A Phase 1 Dose Escalation Study of VX-973 in Healthy Adults
- Registration Number
- NCT05866055
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- Brief Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of VX-973 in healthy participants.
- Detailed Description
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m^2)
- A total body weight of more than (>) 50 kg
- Participants of non-childbearing potential
- Nonsmoker or ex-smoker for at least 3 months before screening
Key
Exclusion Criteria
- History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug
- Any condition possibly affecting drug absorption
Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part A: Single Ascending Dose VX-973 Participants will be randomized to receive a single dose of VX-973 under fasted conditions. Placebo Part A Placebo Participants will be randomized to receive placebo matched to VX-973. Placebo Part B Placebo Participants will be randomized to receive placebo matched to VX-973. Midazolam is planned to be administered as single oral doses of 2 mg first alone on Day -1 and then co-administered with placebo matched to VX-973 on Day 27. Part B: Multiple Ascending Dose VX-973 Participants will be randomized to receive multiple doses of VX-973 under fasted conditions. The dose and frequency will be determined based on Part A. Midazolam is planned to be administered as single oral doses of 2 mg first alone on Day -1 and then co-administered with study drug on Day 27. Part B: Multiple Ascending Dose Midazolam Participants will be randomized to receive multiple doses of VX-973 under fasted conditions. The dose and frequency will be determined based on Part A. Midazolam is planned to be administered as single oral doses of 2 mg first alone on Day -1 and then co-administered with study drug on Day 27. Placebo Part B Midazolam Participants will be randomized to receive placebo matched to VX-973. Midazolam is planned to be administered as single oral doses of 2 mg first alone on Day -1 and then co-administered with placebo matched to VX-973 on Day 27.
- Primary Outcome Measures
Name Time Method Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) From Day 1 up to Day 31 Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) From Day 1 up to Day 43
- Secondary Outcome Measures
Name Time Method Part A: Area Under the Concentration Versus Time Curve (AUC) of VX-973 From Day 1 up to Day 30 Part B: Area Under the Concentration Versus Time Curve (AUC) of VX-973 From Day 1 up to Day 43 Part A: Maximum Observed Plasma Concentration (Cmax) of VX-973 From Day 1 up to Day 30 Part B: Maximum Observed Plasma Concentration (Cmax) of VX-973 From Day 1 up to Day 43 Part B: Maximum Observed Plasma Concentration (Cmax) of Midazolam in the Absence and Presence of VX-973 Days -1 and 27: Pre-dose up to 24 hours Post Midazolam dose Part B: Area Under the Concentration Versus Time Curve (AUC) of Midazolam in the Absence and Presence of VX-973 Days -1 and 27: Pre-dose up to 24 hours Post Midazolam dose
Trial Locations
- Locations (1)
PAREXEL International
🇬🇧Harrow, United Kingdom