73 Participants Needed

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

MI
Overseen ByMedical Information
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Vertex Pharmaceuticals Incorporated
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What is the purpose of this trial?

This trial tests a new drug called VX-548 in healthy people to see how it behaves in their bodies and if it is safe. Researchers want to understand how the drug moves through and affects the body before using it on patients with specific conditions.

Eligibility Criteria

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)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single dose of VX-548 in 1 of 6 treatment sequences with 3 dosing periods to assess different fed conditions and timing of meal administration

6 weeks
3 visits (in-person)

Washout

A 14-day washout period between each dosing period

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

  • VX-548
Participant Groups
1Treatment groups
Experimental Treatment
Group I: VX-548Experimental Treatment1 Intervention
Participants will be randomized to receive a single dose of VX-548 in 1 of 6 treatment sequences with 3 dosing periods to assess different fed conditions and timing of meal administration on the PK of VX 548. There will be a 14 day washout period between each dosing period.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vertex Pharmaceuticals Incorporated

Lead Sponsor

Trials
267
Recruited
36,100+
Dr. David Altshuler profile image

Dr. David Altshuler

Vertex Pharmaceuticals Incorporated

Chief Medical Officer since 2020

MD, PhD

Dr. Reshma Kewalramani profile image

Dr. Reshma Kewalramani

Vertex Pharmaceuticals Incorporated

Chief Executive Officer since 2020

MD, trained in internal medicine and nephrology

Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security