Pain
Conditions
Brief summary
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
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.).
Interventions
DRUGVX-548
Tablets for oral administration.
Sponsors
Vertex Pharmaceuticals Incorporated
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| Maximum Observed Plasma Concentration (Cmax) of VX-548 and its Metabolite | Day 1 to Day 14 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Apparent Clearance of VX-548 | Day 1 to Day 14 |
| Unbound Area Under the Concentration Versus Time Curve of VX-548 and its Metabolite | Day 1 to Day 14 |
| Fraction Unbound (fu) for VX-548 and its Metabolite in Plasma | Day 1 to Day 2 |
| Apparent Renal Clearance of VX-548 and its Metabolite (CLr) | Day 1 to Day 14 |
Countries
United States
Outcome results
None listed