A Study Evaluating the Relative Bioavailability and Food Effect of a Tablet Formulation of VX-147
Study Details
Study Description
Brief Summary
The purpose of the study is to evaluate the relative bioavailability (BA) and the effect of food on the pharmacokinetics (PK), and the safety and tolerability of VX-147 test tablet formulation.
| 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: Sequence A: VX-147 Participants will receive VX-147 reference tablet under fasted condition in Treatment Period 1, then VX-147 test tablet under fed condition in Treatment Period 2, and VX-147 test tablet under fasted condition in Treatment Period 3. A washout period of 5 days will be maintained between 3 treatment periods. |
Drug: VX-147
Tablets for oral administration.
|
| Experimental: Sequence B: VX-147 Participants will receive VX-147 test tablet under fed condition in Treatment Period 1, then VX-147 test tablet under fasted condition in Treatment Period 2, and VX-147 reference tablet under fasted condition in Treatment Period 3. A washout period of 5 days will be maintained between 3 treatment periods. |
Drug: VX-147
Tablets for oral administration.
|
| Experimental: Sequence C: VX-147 Participants will receive VX-147 test tablet under fasted condition in Treatment Period 1, then VX-147 reference tablet under fasted condition in Treatment Period 2, and VX-147 test tablet under fed condition in Treatment Period 3. A washout period of 5 days will be maintained between 3 treatment periods. |
Drug: VX-147
Tablets for oral administration.
|
Outcome Measures
Primary Outcome Measures
- Maximum Observed Plasma Concentration (Cmax) of VX-147 Test Compared to VX-147 Reference [From Day 1 up to Day 16]
- Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-147 Test Compared to VX-147 Reference [From Day 1 up to Day 16]
- Cmax of VX-147 Test Compared Under Fed Versus Fasted State [From Day 1 up to Day 16]
- AUC(0-inf) of VX-147 Test Compared Under Fed Versus Fasted State [From Day 1 up to Day 16]
Secondary Outcome Measures
- Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious AEs [From Day -1 up to Day 27]
Eligibility Criteria
Criteria
Key Inclusion Criteria:
-
Body mass index (BMI) of 18.0 to 32.0 kilogram per square meter (kg/m^2), inclusive
-
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
Other protocol defined Inclusion/Exclusion criteria may apply.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Vertex Pharmaceuticals Incorporated
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VX22-147-010