Pain
Conditions
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.).
Interventions
DRUGVX-548
Tablets for oral administration.
DRUGOmeprazole
Tablets for oral administration.
DRUGRifampin
Capsules for oral administration.
Sponsors
Vertex Pharmaceuticals Incorporated
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| Part A:Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Day 1 through Safety Follow-up Visit (up to 28 days) |
| Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Day 1 through Safety Follow-up Visit (up to 34 days) |
Countries
Australia
Outcome results
None listed