A Phase 1 Study to Evaluate the Relative Bioavailability of a VX-828 Tablet Formulation

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

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2025-05-05

Brief Summary

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The purpose of this study is to evaluate the relative bioavailability of a VX-828 tablet formulation compared to a suspension and evaluate its safety and tolerability.

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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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Cystic Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1

Participants will be randomized to receive a single dose of VX-828 suspension.

Group Type ACTIVE_COMPARATOR

VX-828

Intervention Type DRUG

Suspension for Oral Administration.

Cohort 2

Participants will be randomized to receive a single dose of VX-828 tablets.

Group Type EXPERIMENTAL

VX-828

Intervention Type DRUG

Tablets for Oral Administration.

Interventions

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VX-828

Tablets for Oral Administration.

Intervention Type DRUG

VX-828

Suspension 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)
* A total body weight of more than (\>) 50 Kg
* Nonsmoker or ex-smoker for at least 3 months before screening
* Participants of non-childbearing potential

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