A Study Evaluating the Relative Bioavailability and Food Effect of a Tablet Formulation of VX-147

Study Overview
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Brief Summary
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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
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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.).

Official Title
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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

Conditions
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Focal Segmental Glomerulosclerosis (FSGS)

Intervention / Treatment
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* Drug: VX-147


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence A: VX-147<br>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<br>* Tablets for oral administration.<br>|
| Experimental: Sequence B: VX-147<br>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<br>* Tablets for oral administration.<br>|
| Experimental: Sequence C: VX-147<br>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<br>* Tablets for oral administration.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious AEs |  | From Day -1 up to Day 27 |