A Phase 1 Study to Evaluate Safety, Tolerability, and Pharmacokinetics of VX-407 in Healthy Participants
Phase 1
Recruiting
- Conditions
- Autosomal Dominant Polycystic Kidney Disease (ADPKD)
- Interventions
- Registration Number
- NCT06345755
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- Brief Summary
The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetic parameters 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
- RECRUITING
- Sex
- All
- Target Recruitment
- 119
Inclusion Criteria
- 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
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 (SAD) VX-407 Participants will be randomized to receive a single dose of different dose levels of VX-407. Part A: Placebo Placebo Participants will be randomized to receive placebo matched to VX-407. Part B: Multiple Ascending Dose (MAD) VX-407 Participants will be randomized to receive multiple doses of different dose levels of VX-407. The dose levels will be determined based on the data from Part A. Part B: Placebo Placebo Participants will be randomized to receive multiple doses of placebo matched to VX-407. Part C: Drug-Drug Interaction VX-407 Participants will be administered Midazolam (MDZ) in the presence or absence of VX-407. The dose levels will be determined based on the data from Part B. Part C: Drug-Drug Interaction Midazolam Participants will be administered Midazolam (MDZ) in the presence or absence of VX-407. The dose levels will be determined based on the data from Part B. Part D VX-407 Participants will be randomized to receive VX-407 in 1 of 3 treatment sequences with 3 dosing periods to assess the relative bioavailability of VX-407 formulations and the effect of food on the pharmacokinetics of 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 Plasma Concentration (Cmax) of VX-407 From Day 1 up to Day 6 Part B: Area Under the Concentration Versus Time Curve (AUC) of VX-407 Days 1, 7, and 14 Part C: Area Under the Concentration Versus Time Curve (AUC) of MDZ in Absence and Presence of VX-407 On Day 1, and Day 15 Part B: Maximum Observed Plasma Concentration (Cmax) of VX-407 Days 1, 7, and 14 Part C: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) From Enrollment up to Day 24 Part A: Area Under the Concentration Versus Time Curve (AUC) of VX-407 From Day 1 up to Day 6 Part C: Maximum Observed Plasma Concentration (Cmax) of MDZ in Absence and Presence of VX-407 On Day 1, and Day 15 Part D: Maximum Observed Plasma Concentration (Cmax) of VX-407 Tablet Formulation (test) compared to a Suspension Formulation (reference) Under Fasted Conditions Days 1, 7, and 13 Part D: Maximum Observed Plasma Concentration (Cmax) of VX-407 Tablet Formulation Under Fed versus Fasted State Days 1, 7, and 13 Part D: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-407 Under Fasted Conditions Days 1, 7, and 13 Part D: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-407 Tablet Formulation Under Fed versus Fasted State Days 1, 7, and 13 Part D: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) From Enrollment up to Day 22
Trial Locations
- Locations (2)
Altasciences Montreal
🇨🇦Montreal, Canada
ICON Lenexa
🇺🇸Lenexa, Kansas, United States