A Phase 1 Study Evaluating Safety, Tolerability, and Pharmacokinetics of VX-407 in Healthy Participants
- Conditions
- Autosomal Dominant Polycystic Kidney Disease (ADPKD)
- Interventions
- Drug: Placebo
- Registration Number
- NCT07022119
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- Brief Summary
The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of VX-407 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
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 24
- Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m^2)
- A total body weight of greater than (>) 50 kg
- Nonsmoker or ex-smoker for at least 3 months before screening
Key
- 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 will apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part A: Single Ascending Dose VX-407 Participants will be randomized to receive a single dose of VX-407. Placebo Part A Placebo Participants will be randomized to receive placebo matched to VX-407. Part B: Multiple Ascending Dose VX-407 Participants will be randomized to receive multiple doses of VX-407. Placebo Part B Placebo Participants will be randomized to receive placebo matched to VX-407.
- 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 Enrollment up to Day 10 Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) From Enrollment up to Day 23
- Secondary Outcome Measures
Name Time Method Part A: Maximum Observed Concentration (Cmax) of VX-407 in Plasma From Day 1 up to Day 6 Part B: Cmax of VX-407 in Plasma Days 1, 7, and 14 up to Day 19 Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-407 in Plasma From Day 1 up to Day 6 Part B: Area Under the Concentration Time-curve From 0 to 24 Hours (AUC0-24hr) of VX-407 in Plasma Days 1, 7, and 14 up to Day 19 Part A: Time Taken for VX-407 to Reach Maximum Concentration (tmax) From Day 1 up to Day 6 Part B: Time Taken for VX-407 to Reach Maximum Concentration (tmax) Days 1, 7, and 14 up to Day 19 Part A: Renal Clearance (CLr) of VX-407 From Day 1 up to Day 6 Part B: CLr of VX-407 Day 1 and Day 14
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