Clinical trial NCT07022119: A Phase 1 Study Evaluating Safety, Tolerability, and Pharmacokinetics of VX-407 in Healthy Participants
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Dose Extension Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of VX-407 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2025-06-15
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.).

Eligibility criteria: Key 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 will apply.

Primary outcomes:
measure: Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From Enrollment up to Day 10
measure: Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From Enrollment up to Day 23
Secondary outcomes:
measure: Part A: Maximum Observed Concentration (Cmax) of VX-407 in Plasma
timeFrame: From Day 1 up to Day 6
measure: Part B: Cmax of VX-407 in Plasma
timeFrame: Days 1, 7, and 14 up to Day 19
measure: Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-407 in Plasma
timeFrame: From Day 1 up to Day 6
measure: Part B: Area Under the Concentration Time-curve From 0 to 24 Hours (AUC0-24hr) of VX-407 in Plasma
timeFrame: Days 1, 7, and 14 up to Day 19
measure: Part A: Time Taken for VX-407 to Reach Maximum Concentration (tmax)
timeFrame: From Day 1 up to Day 6
measure: Part B: Time Taken for VX-407 to Reach Maximum Concentration (tmax)
timeFrame: Days 1, 7, and 14 up to Day 19
measure: Part A: Renal Clearance (CLr) of VX-407
timeFrame: From Day 1 up to Day 6
measure: Part B: CLr of VX-407
timeFrame: Day 1 and Day 14
Other outcomes:
Locations:
Study officials:
References: