A Study to Evaluate the Pharmacokinetic Drug-drug Interactions Between VX-548, Midazolam, and Digoxin

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

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-22

Study Completion Date

2023-04-28

Brief Summary

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The purpose of this study is to evaluate the pharmacokinetics of midazolam and digoxin in the absence and presence of VX-548.

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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

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Arm 1

Participants will receive a single dose of midazolam and digoxin on Day 1 in dosing period 1 followed by VX-548 every 12 hours (q12h) on Days 6 through 23 in dosing period 2. On Day 19, single doses of midazolam and digoxin will be administered with the morning dose of VX-548.

Group Type EXPERIMENTAL

VX-548

Intervention Type DRUG

Tablets for oral administration.

Midazolam

Intervention Type DRUG

Syrup for oral administration.

Digoxin

Intervention Type DRUG

Tablets for oral administration.

Interventions

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VX-548

Tablets for oral administration.

Intervention Type DRUG

Midazolam

Syrup for oral administration.

Intervention Type DRUG

Digoxin

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)
* Females of non-childbearing potential

Exclusion Criteria

* History of febrile illness or other acute illness that has not fully resolved within 5 days before the first dose of study drug
* Any condition possibly affecting drug absorption
* History of cardiovascular disease, cardiac dysrhythmias or central nervous system disease
* Hypersensitivity to midazolam, other benzodiazepines, or digoxin

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes