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

• Status: Not yet recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

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 renal impairment and healthy participants.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Vertex Pharmaceuticals Incorporated

Criteria

Key Inclusion Criteria:

• Cohort 1: Participants with Severe Renal Impairment

• Body mass index (BMI) of 18.0 to 38.0 kilogram per square meter (kg/m^2)

• Stable renal function for at least 1 month prior to enrollment, as assessed by the site investigator

• Cohort 2: Matched Healthy Participants

• Participants will be matched to Cohort 1 participants according to each of the following parameters: sex, age (±10 years), and BMI (±15%)

Key Exclusion Criteria:

• Cohorts 1: Participants with Severe Renal Impairment

• Hemoglobin less than or equal to (≤) 9.0 gram per deciliter (g/dL) at screening

• Cohort 2: Matched Healthy Participants

• Prior renal transplantation, prior hemodialysis, or prior peritoneal dialysis

• All Cohorts:

• Participants of childbearing potential

• History of febrile or acute illness that has not fully resolved by 14 days before the first dose of study drug.

• Any condition possibly affecting drug absorption

Other protocol defined Inclusion/Exclusion criteria may apply.