Clinical trial NCT06345755: A Phase 1 Study to Evaluate Safety, Tolerability, and Pharmacokinetics of VX-407 in Healthy Participants
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, First-in-human Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of VX-407 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2024-04-03
Enrollment: 159
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 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.).

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 may 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 Plasma Concentration (Cmax) of VX-407
timeFrame: From Day 1 up to Day 6
measure: Part B: Maximum Observed Plasma Concentration (Cmax) of VX-407
timeFrame: Days 1, 7, and 14
measure: Part A: Area Under the Concentration Versus Time Curve (AUC) of VX-407
timeFrame: From Day 1 up to Day 6
measure: Part B: Area Under the Concentration Versus Time Curve (AUC) of VX-407
timeFrame: Days 1, 7, and 14
measure: Part C: Area Under the Concentration Versus Time Curve (AUC) of MDZ in Absence and Presence of VX-407
timeFrame: On Day 1, and Day 15
measure: Part C: Maximum Observed Plasma Concentration (Cmax) of MDZ in Absence and Presence of VX-407
timeFrame: On Day 1, and Day 15
measure: Part C: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From Enrollment up to Day 24
measure: Part D: Maximum Observed Plasma Concentration (Cmax) of VX-407 Tablet Formulation (test) compared to a Suspension Formulation (reference) Under Fasted Conditions
timeFrame: Days 1, 7, and 13
measure: 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
timeFrame: Days 1, 7, and 13
measure: Part D: Maximum Observed Plasma Concentration (Cmax) of VX-407 Tablet Formulation Under Fed versus Fasted State
timeFrame: Days 1, 7, and 13
measure: 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
timeFrame: Days 1, 7, and 13
measure: Part D: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From Enrollment up to Day 22
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: ICON Lenexa
state: Kansas
city: Montreal
country: Canada
facility: Altasciences Montreal
Study officials:
References: