A Phase 1, Open-label Study to Evaluate the Pharmacokinetics and Safety of Multiple Doses of VX-548 in Subjects With Mild or Moderate Hepatic Impairment and in Matched Healthy Subjects
Abstract
The purpose of this study is to evaluate the pharmacokinetics and safety of multiple doses of VX-584 in participants with mild or moderate hepatic impairment as compared to matched healthy controls.
Conditions: Pain.
Primary outcome: Maximum Observed Plasma Concentration (Cmax) of VX-548; Area Under the Plasma Concentration Versus Time Curve During a Dosing Interval (AUCtau) of VX-548; Time Taken for VX-548 to Reach Maximum Concentration (tmax); Time Required for Plasma Concentration of VX-548 to Reduce to Half (t1/2); Apparent Volume of Distribution of VX-548 (Vz/F); Apparent Clearance of VX-548 (CL/F); Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to the Last Measured Concentration (AUC0-last) of VX-548.
Enrollment: 36 participants.
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 36 participants or records.
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