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NCT05704556
Evaluation of the Pharmacokinetics and Safety of VX 548 in Participants With Severe Renal Impairment
Conditions: Pain
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: 1
Phase: PHASE1
Enrollment: 18
Sponsor: Vertex Pharmaceuticals Incorporated
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.
Eligibility Criteria
Key Inclusion Criteria:Cohort 1: Participants with Severe Renal ImpairmentBody 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 investigatorCohort 2: Matched Healthy ParticipantsParticipants 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 ImpairmentHemoglobin less than or equal to (≤) 9.0 gram per deciliter (g/dL) at screeningCohort 2: Matched Healthy ParticipantsPrior renal transplantation, prior hemodialysis, or prior peritoneal dialysisAll Cohorts:Participants of childbearing potentialHistory 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 absorptionOther protocol defined Inclusion/Exclusion criteria may apply.
Source: ClinicalTrials.gov (NCT05704556). StuddyBuddy aggregates publicly available trial information.