Clinical trial NCT05635110: Evaluation of the Effects of Omeprazole and Rifampin on the Pharmacokinetics of VX-548 in Healthy Participants
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2022-12-02
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

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.).

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.

Primary outcomes:
measure: Part A: Maximum Observed Plasma Concentration (Cmax) of VX-548 and its Metabolite in the Absence and Presence of Omeprazole
timeFrame: Day 1 up to Day 22
measure: 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
timeFrame: Day 1 up to Day 22
measure: Part B: Maximum Observed Plasma Concentration (Cmax) of VX-548 and its Metabolite in the Absence and Presence of Rifampin
timeFrame: Day 1 up to Day 28
measure: 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
timeFrame: Day 1 up to Day 28
Secondary outcomes:
measure: Part A:Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Day 1 through Safety Follow-up Visit (up to 28 days)
measure: Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Day 1 through Safety Follow-up Visit (up to 34 days)
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: CMAX Clinical Research
Study officials:
References: