A Study to Evaluate the Effect of VX-548 on the QT/QTc Interval 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

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-12

Study Completion Date

2023-06-28

Brief Summary

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The purpose of the study is to evaluate the effects of clinical and high clinical exposures of VX-548 and its metabolite on QTcF, and the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of VX-548 and its metabolite.

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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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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group 1

Participants will receive VX-548-matching placebo, moxifloxacin-matching placebo and VX-548 at different time points.

Group Type EXPERIMENTAL

VX-548

Intervention Type DRUG

Tablets for oral administration.

Moxifloxacin Placebo

Intervention Type DRUG

Capsules for oral administration.

VX-548 Placebo

Intervention Type DRUG

Tablets for oral administration.

Group 2A

Participants will receive VX-548-matching placebo, moxifloxacin and moxifloxacin-matching placebo at different time points.

Group Type ACTIVE_COMPARATOR

Moxifloxacin

Intervention Type DRUG

Capsules for oral administration.

Moxifloxacin Placebo

Intervention Type DRUG

Capsules for oral administration.

VX-548 Placebo

Intervention Type DRUG

Tablets for oral administration.

Group 2B

Participants will receive VX-548-matching placebo, moxifloxacin-matching placebo and moxifloxacin at different time points.

Group Type ACTIVE_COMPARATOR

Moxifloxacin

Intervention Type DRUG

Capsules for oral administration.

Moxifloxacin Placebo

Intervention Type DRUG

Capsules for oral administration.

VX-548 Placebo

Intervention Type DRUG

Tablets for oral administration.

Interventions

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VX-548

Tablets for oral administration.

Intervention Type DRUG

Moxifloxacin

Capsules for oral administration.

Intervention Type DRUG

Moxifloxacin Placebo

Capsules for oral administration.

Intervention Type DRUG

VX-548 Placebo

Tablets for oral administration.

Intervention Type DRUG

Other Intervention Names

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Suzetrigine

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 greater than (\>) 50 kilogram (kg)

Exclusion Criteria

* History of febrile illness within 5 days before the first dose of study drug
* Any condition possibly affecting drug absorption
* Known hypersensitivity or prior adverse reaction to moxifloxacin or other quinolones

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes