Evaluation of the Pharmacokinetics and Safety of VX 548 in Participants With Renal Impairment
Pain
About this trial
This is an interventional treatment trial for Pain
Eligibility Criteria
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.
Sites / Locations
- Clinical Pharmacology of Miami, LLCRecruiting
- GCP ResearchRecruiting
- Genesis Clinical ResearchRecruiting
- Southwest Houston Research, LtdRecruiting
- Clinical Trials of Texas, LLCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Cohort 1: Severe Renal Impairment
Cohort 2: Matched Healthy Participants
Cohort 3: Moderate Renal Impairment
Cohort 4: Matched Healthy Participants
Participants will receive a single dose of VX-548 in a fasted state.
Healthy participants matched to cohort 1 will receive a single doses of VX-548 in a fasted state.
Participants will receive a single dose of VX-548 in a fasted state.
Healthy participants matched to cohort 3 will receive a single dose of VX-548 in a fasted state.