Evaluation of the Pharmacokinetics and Safety of VX 548 in Participants With Renal Impairment

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of VX-548 and its metabolite in participants with severe or moderate renal impairment and healthy participants.

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 Study to Evaluate the Pharmacokinetics and Safety of Single Doses of VX-548 in Subjects With Severe or Moderate Renal Impairment and in Matched Healthy Subjects

Conditions
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Pain

Intervention / Treatment
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* Drug: VX-548


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Cohorts 1 and 3: Participants with Severe or Moderate Renal Impairment Body mass index (BMI) of greater than or equal to (>=)18.0 to less than (<) 40.0 kilogram per square meter (kg/m^2) Stable renal function as pre-defined in the protocol Cohorts 2 and 4: Matched Healthy Participants Healthy participants will be matched to Cohorts 1 and 3 participants according to each of the following parameters: sex, age (±10 years), and BMI (±15%) Key Exclusion Criteria: Cohorts 1 and 3: Participants with Severe or Moderate Renal Impairment Hemoglobin less than or equal to (≤) 9.0 gram per deciliter (g/dL) at screening Cohorts 2 and 4: Matched Healthy Participants Prior renal transplantation, prior hemodialysis, or prior peritoneal dialysis All Cohorts: History of febrile or acute illness that has not fully resolved by 14 days before study drug dosing. 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: 75 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1: Severe Renal Impairment<br>Participants will receive a single dose of VX-548 in a fasted state. | Drug: VX-548<br>* Tablets for oral administration.<br>|
| Experimental: Cohort 2: Matched Healthy Participants<br>Healthy participants matched to cohort 1 will receive a single doses of VX-548 in a fasted state. | Drug: VX-548<br>* Tablets for oral administration.<br>|
| Experimental: Cohort 3: Moderate Renal Impairment<br>Participants will receive a single dose of VX-548 in a fasted state. | Drug: VX-548<br>* Tablets for oral administration.<br>|
| Experimental: Cohort 4: Matched Healthy Participants<br>Healthy participants matched to cohort 3 will receive a single dose of VX-548 in a fasted state. | Drug: VX-548<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-548 and its Metabolite |  | Day 1 to Day 14 | 
| Area Under the Plasma Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-548 and its Metabolite |  | Day 1 to Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apparent Clearance of VX-548 |  | Day 1 to Day 14 | 
| Apparent Renal Clearance of VX-548 and its Metabolite (CLr) |  | Day 1 to Day 14 | 
| Apparent Non-Renal Clearance of VX-548 |  | Day 1 to Day 14 | 
| Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |  | Day 1 to Day 23 | 
| Fraction Unbound (fu) for VX-548 and its Metabolite in Plasma |  | Day 1 to Day 2 | 
| Unbound Area Under the Concentration Versus Time Curve of VX-548 and its Metabolite |  | Day 1 to Day 14 |