Evaluation of the Pharmacokinetics and Safety of VX-548 in Participants With Renal Impairment
- Registration Number
- NCT05704556
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- 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.).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
-
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
-
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1: Severe Renal Impairment VX-548 Participants will receive a single dose of VX-548 in a fasted state. Cohort 4: Matched Healthy Participants VX-548 Healthy participants matched to cohort 3 will receive a single dose of VX-548 in a fasted state. Cohort 2: Matched Healthy Participants VX-548 Healthy participants matched to cohort 1 will receive a single doses of VX-548 in a fasted state. Cohort 3: Moderate Renal Impairment VX-548 Participants will receive a single dose of VX-548 in a fasted state.
- Primary Outcome Measures
Name Time Method 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
Name Time Method Apparent Renal Clearance of VX-548 and its Metabolite (CLr) 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 Non-Renal Clearance of VX-548 Day 1 to Day 14 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 Apparent Clearance of VX-548 Day 1 to Day 14
Trial Locations
- Locations (7)
Southwest Houston Research, Ltd
🇺🇸Houston, Texas, United States
Clinical Pharmacology of Miami, LLC
🇺🇸Miami, Florida, United States
Genesis Clinical Research
🇺🇸Tampa, Florida, United States
Elixia, Phase 1 Clinical Site
🇺🇸Tampa, Florida, United States
Clinical Trials of Texas, LLC
🇺🇸San Antonio, Texas, United States
Infigo Clinical Research
🇺🇸DeLand, Florida, United States
GCP Research
🇺🇸Saint Petersburg, Florida, United States