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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

159 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-17

Study Completion Date

2025-06-13

Brief Summary

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

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Detailed Description

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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.).

Conditions

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Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Part A: Single Ascending Dose (SAD)

Participants will be randomized to receive a single dose of different dose levels of VX-407.

Group Type EXPERIMENTAL

VX-407

Intervention Type DRUG

Solution or Suspension for oral administration.

Part A: Placebo

Participants will be randomized to receive placebo matched to VX-407.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Solution or Suspension for oral administration.

Part B: Multiple Ascending Dose (MAD)

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.

Group Type EXPERIMENTAL

VX-407

Intervention Type DRUG

Solution or Suspension for oral administration.

Part B: Placebo

Participants will be randomized to receive multiple doses of placebo matched to VX-407.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Solution or Suspension for oral administration.

Part C: Drug-Drug Interaction

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.

Group Type EXPERIMENTAL

VX-407

Intervention Type DRUG

Solution or Suspension for oral administration.

Midazolam

Intervention Type DRUG

Syrup for oral administration.

Part D

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.

Group Type EXPERIMENTAL

VX-407

Intervention Type DRUG

Suspension or Tablets for oral administration.

Interventions

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VX-407

Solution or Suspension for oral administration.

Intervention Type DRUG

Placebo

Solution or Suspension for oral administration.

Intervention Type DRUG

Midazolam

Syrup for oral administration.

Intervention Type DRUG

VX-407

Suspension or Tablets for oral administration.

Intervention Type DRUG

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes