Evaluation of the Effects of Omeprazole and Rifampin on the Pharmacokinetics of VX-548 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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-15

Study Completion Date

2023-06-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate the pharmacokinetics and safety of VX-548 and its metabolite in the absence and presence of omeprazole or rifampin, in healthy participants.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Assessment of Pharmacokinetics of a Single Oral Dose of VIMOVO in Healthy Adult Volunteers

NCT01358383

Juvenile Idiopathic Arthritis

COMPLETED PHASE1

Pharmacokinetics Study of XG005 Capsule

NCT04499209

Pain

COMPLETED PHASE1

Drug-drug Interaction Study to Evaluate the Effect of Omeprazole on CG5503 (Tapentadol)

NCT03979989

Pharmacokinetic

COMPLETED PHASE1

A Pharmacokinetic (PK) Study Evaluating Naproxen and Esomeprazole Plasma Levels

NCT00749385

Arthritis

COMPLETED PHASE1

Phase I Study PK Study With OXP005 and Naprosyn

NCT02351024

Pharmacokinetics

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Part A

Participants will receive a single dose of VX-548 on Day 1 and a single dose of omeprazole once daily (qd) on Days 10 through Day 12. On Day 13, participants will receive omeprazole followed by VX-548 under fasted conditions.

Group Type EXPERIMENTAL

VX-548

Intervention Type DRUG

Tablets for oral administration.

Omeprazole

Intervention Type DRUG

Tablets for oral administration.

Part B

Participants will receive a single dose of VX-548 on Day 1 followed by rifampin qd on Days 10 through Day 27. On Day 19, participants will be co-administered rifampin and VX-548 under fasted conditions.

Group Type EXPERIMENTAL

VX-548

Intervention Type DRUG

Tablets for oral administration.

Rifampin

Intervention Type DRUG

Capsules for oral administration.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

VX-548

Tablets for oral administration.

Intervention Type DRUG

Omeprazole

Tablets for oral administration.

Intervention Type DRUG

Rifampin

Capsules for oral administration.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Suzetrigine

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
* History of cardiovascular disease
* Participants of child-bearing potential

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes