A Phase 1, Open Label, Randomized, Crossover Study Evaluating the Relative Bioavailability and Food Effect of a VX-147 Test Tablet Formulation Compared to a Reference Tablet Formulation in Healthy Adult Subjects
Overview
- Phase
- Phase 1
- Intervention
- VX-147
- Conditions
- Focal Segmental Glomerulosclerosis (FSGS)
- Sponsor
- Vertex Pharmaceuticals Incorporated
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
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.).
Investigators
Eligibility Criteria
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
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.
Arms & Interventions
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.
Intervention: VX-147
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.
Intervention: VX-147
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.
Intervention: VX-147
Outcomes
Primary Outcomes
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
Time Frame: From Day 1 up to Day 16
Maximum Observed Plasma Concentration (Cmax) of VX-147 Test Compared to VX-147 Reference
Time Frame: From Day 1 up to Day 16
Cmax of VX-147 Test Compared Under Fed Versus Fasted State
Time Frame: From Day 1 up to Day 16
AUC(0-inf) of VX-147 Test Compared Under Fed Versus Fasted State
Time Frame: From Day 1 up to Day 16
Secondary Outcomes
- Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious AEs(From Day -1 up to Day 27)