A Study to Evaluate the Effect of Food on the Pharmacokinetics of VX-548

A Phase 1, Randomized, Open-label, Crossover Study Evaluating the Effects of Food on the Pharmacokinetics of VX-548 in Healthy Adults

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05851157

Enrollment

Registered

2023-05-09

Start date

2023-05-03

Completion date

2023-11-08

Last updated

2024-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Brief summary

The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of VX-548 in healthy participants.

Detailed description

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.).

Interventions

DRUGVX-548

Tablets for oral administration.

Study design

Allocation

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

Key Inclusion Criteria: * Body mass index (BMI) of 18.0 to 35.0 kilogram per meter square (Kg/m\^2) * A total body weight greater than (\>) 50 kilogram (kg) Key

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 * Participants of childbearing potential Other protocol defined Inclusion/

Design outcomes

Primary

Measure	Time frame
Maximum Observed Plasma Concentration (Cmax) of VX-548 and its Metabolite	Pre-dose up to Day 35 Post-dose
Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC0-tlast) of VX-548 and its Metabolite	Pre-dose up to Day 35 Post-dose
Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-548 and its Metabolite	Pre-dose up to Day 35 Post-dose

Secondary

Measure	Time frame
Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)	From Day 1 up to Day 44

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026