A Phase 1 Study to Evaluate Safety, Tolerability, and Pharmacokinetics of VX-407 in Healthy Participants

Vertex Pharmaceuticals Incorporated159 enrolled

Overview

The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetic parameters of VX-407 in healthy participants.

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.).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

159

Conditions

Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Interventions

VX-407DRUG

Solution or Suspension for oral administration.

PlaceboDRUG

Solution or Suspension for oral administration.

MidazolamDRUG

Syrup for oral administration.

VX-407

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

ICON Lenexa

Lenexa, Kansas, United States

Altasciences Montreal

Montreal, Canada

Outcomes

Primary Outcomes

Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame: 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)

Time frame: From Enrollment up to Day 23

Secondary Outcomes

Part A: Maximum Observed Plasma Concentration (Cmax) of VX-407

Time frame: From Day 1 up to Day 6

Part B: Maximum Observed Plasma Concentration (Cmax) of VX-407

Time frame: Days 1, 7, and 14

Part A: Area Under the Concentration Versus Time Curve (AUC) of VX-407

Time frame: From Day 1 up to Day 6

Part B: Area Under the Concentration Versus Time Curve (AUC) of VX-407

Time frame: Days 1, 7, and 14

Part C: Area Under the Concentration Versus Time Curve (AUC) of MDZ in Absence and Presence of VX-407

Time frame: On Day 1, and Day 15

Part C: Maximum Observed Plasma Concentration (Cmax) of MDZ in Absence and Presence of VX-407

Time frame: On Day 1, and Day 15

Part C: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame: From Enrollment up to Day 24

Part D: Maximum Observed Plasma Concentration (Cmax) of VX-407 Tablet Formulation (test) compared to a Suspension Formulation (reference) Under Fasted Conditions

Data from ClinicalTrials.gov

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