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A Study to Evaluate the Relative Bioavailability and Food Effect of a New Tablet Formulation of VX-548

NCT ID: NCT05455502

Last Updated: 2024-03-20

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-13

Study Completion Date

2022-09-17

Brief Summary

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The purpose of this study is to evaluate the relative bioavailability and food effect of a new tablet formulation of VX-548 in healthy adult 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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Pain

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 1

Participants will receive VX-548 reference tablet (TF1) under fasted condition in dosing period 1, then VX-548 test tablet (TF2) under fasted condition in dosing period 2, and finally VX-548 test tablet (TF2) under fed condition in dosing period 3. A washout period of 12 days will be maintained between 3 dosing periods.

Group Type EXPERIMENTAL

VX-548

Intervention Type DRUG

Tablet for oral administration.

Sequence 2

Participants will receive VX-548 TF1 under fasted condition in dosing period 1, then VX-548 TF2 under fed condition in dosing period 2, and finally VX-548 TF2 under fasted condition in dosing period 3. A washout period of 12 days will be maintained between 3 dosing periods.

Group Type EXPERIMENTAL

VX-548

Intervention Type DRUG

Tablet for oral administration.

Sequence 3

Participants will receive VX-548 TF2 under fasted condition in dosing period 1, then VX-548 TF1 under fasted condition in dosing period 2, and finally VX-548 TF2 under fed condition in dosing period 3. A washout period of 12 days will be maintained between 3 dosing periods.

Group Type EXPERIMENTAL

VX-548

Intervention Type DRUG

Tablet for oral administration.

Sequence 4

Participants will receive VX-548 TF2 under fasted condition in dosing period 1, then VX-548 TF2 under fed condition in dosing period 2, and finally VX-548 TF1 under fasted condition in dosing period 3. A washout period of 12 days will be maintained between 3 dosing periods.

Group Type EXPERIMENTAL

VX-548

Intervention Type DRUG

Tablet for oral administration.

Sequence 5

Participants will receive VX-548 TF2 under fed condition in dosing period 1, then VX-548 TF1 under fasted condition in dosing period 2, and finally VX-548 TF2 under fasted condition in dosing period 3. A washout period of 12 days will be maintained between 3 dosing periods.

Group Type EXPERIMENTAL

VX-548

Intervention Type DRUG

Tablet for oral administration.

Sequence 6

Participants will receive VX-548 TF2 under fed condition in dosing period 1, then VX-548 TF2 under fasted condition in dosing period 2, and finally VX-548 TF1 under fasted condition in dosing period 3. A washout period of 12 days will be maintained between 3 dosing periods.

Group Type EXPERIMENTAL

VX-548

Intervention Type DRUG

Tablet for oral administration.

Interventions

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VX-548

Tablet 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 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
* Female participants of childbearing potential
* Male participants with a female partner who is pregnant, nursing, or planning to become pregnant during the study
* History of cardiovascular disease, cardiac dysrhythmias or central nervous system disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vertex Pharmaceuticals Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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ICON Salt Lake City

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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VX21-548-011

Identifier Type: -

Identifier Source: org_study_id

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