A Study Evaluating the Relative Bioavailability and Food Effect of a Tablet Formulation of VX-147

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

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-19

Study Completion Date

2023-09-02

Brief Summary

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The purpose of the study is to evaluate the relative bioavailability (BA) and the effect of food on the pharmacokinetics (PK), and the safety and tolerability of VX-147 test tablet formulation.

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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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Focal Segmental Glomerulosclerosis (FSGS)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sequence A: VX-147

Participants will receive VX-147 reference tablet under fasted condition in Treatment Period 1, then VX-147 test tablet under fed condition in Treatment Period 2, and VX-147 test tablet under fasted condition in Treatment Period 3. A washout period of 5 days will be maintained between 3 treatment periods.

Group Type EXPERIMENTAL

VX-147

Intervention Type DRUG

Tablets for oral administration.

Sequence B: VX-147

Participants will receive VX-147 test tablet under fed condition in Treatment Period 1, then VX-147 test tablet under fasted condition in Treatment Period 2, and VX-147 reference tablet under fasted condition in Treatment Period 3. A washout period of 5 days will be maintained between 3 treatment periods.

Group Type EXPERIMENTAL

VX-147

Intervention Type DRUG

Tablets for oral administration.

Sequence C: VX-147

Participants will receive VX-147 test tablet under fasted condition in Treatment Period 1, then VX-147 reference tablet under fasted condition in Treatment Period 2, and VX-147 test tablet under fed condition in Treatment Period 3. A washout period of 5 days will be maintained between 3 treatment periods.

Group Type EXPERIMENTAL

VX-147

Intervention Type DRUG

Tablets for oral administration.

Interventions

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VX-147

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 square meter (kg/m\^2), inclusive
* A total body weight greater than 50 kg

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