Evaluation of the Effects of Omeprazole and Rifampin on the Pharmacokinetics of VX-548 in Healthy Participants
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
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.).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Drug: VX-548
Tablets for oral administration.
Drug: Omeprazole
Tablets for oral administration.
|
| Experimental: 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. |
Drug: VX-548
Tablets for oral administration.
Drug: Rifampin
Capsules for oral administration.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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)]
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CMAX Clinical Research | Adelaide | Australia |
Sponsors and Collaborators
- Vertex Pharmaceuticals Incorporated
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VX22-548-013