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

Vertex Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Pain

Treatments: Drug: Rifampin; Drug: Omeprazole; Drug: VX-548

Study type: Interventional

Funder types: Industry

Identifiers

NCT05635110

VX22-548-013

Details and patient eligibility

About

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.

Full 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.).

Enrollment: 31 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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31 participants in 2 patient groups

Part A

Experimental group

Description:

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.

Treatment:

Drug: Omeprazole

Drug: VX-548

Part B

Experimental group

Description:

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.

Treatment:

Drug: Rifampin

Drug: VX-548