Clinical trial

A Phase 1, Open-label Drug-drug Interaction Study to Evaluate the Effects of Omeprazole and Rifampin on the Pharmacokinetics of VX-548 in Healthy Subjects

Name

VX22-548-013

Description

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.

Trial arms

Trial start

2022-12-15

Estimated PCD

2023-06-08

Trial end

2023-06-08

Status

Completed

Phase

Early phase I

Treatment

VX-548

Tablets for oral administration.

Arms:

Part A, Part B

Other names:

Suzetrigine

Omeprazole

Tablets for oral administration.

Arms:

Part A

Rifampin

Capsules for oral administration.

Arms:

Part B

Size

Primary endpoint

Part A: Maximum Observed Plasma Concentration (Cmax) of VX-548 and its Metabolite in the Absence and Presence of Omeprazole

Day 1 up to Day 22

Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-548 and its Metabolite in the Absence and Presence of Omeprazole

Day 1 up to Day 22

Part B: Maximum Observed Plasma Concentration (Cmax) of VX-548 and its Metabolite in the Absence and Presence of Rifampin

Day 1 up to Day 28

Part B: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-548 and its Metabolite in the Absence and Presence of Rifampin

Day 1 up to Day 28

Eligibility criteria

Key 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 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 * History of cardiovascular disease * Participants of child-bearing potential Other protocol defined Inclusion/Exclusion criteria may apply.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 31, 'type': 'ACTUAL'}}

Updated at

2024-03-20

1 organization

3 products

1 indication

Product

VX-548

Indication

Pain

Organization

Vertex Pharmaceuticals

Product

Omeprazole

Product

Rifampin