Concert Pharmaceuticals is recruiting patients for the clinical trial of Study to Assess the Effect of Hepatic Impairment on the Pharmacokinetics of CTP-543.
This is an open-label, single-dose, single-period, parallel group designed study to determine the effect of mild and moderate hepatic impairment on the pharmacokinetics (PK) of CTP-543 and its major metabolites following administration of a single 12 mg oral dose of CTP-543.
The researchers plan that June 1, 2022 will be the study start date. The indicative completion of the clinical trial will be expected in October 2022.
Among primary outcome measures are the Single dose PK exposure: Area Under the Concentration-Time Curve from time 0 extrapolated to infinity (AUC0-inf) and Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinity, calculated by linear-log trapezoidal summation and extrapolated to infinity by addition of the last quantifiable concentration divided by the elimination rate constant.
The study will take place at the Orlando Clinical Research Center, Orlando, Florida, United States; Alliance for Multispecialty Research, LLC, Knoxville, Tennessee, United States.
The page dedicated to this clinical trial can be found here: https://ichgcp.net/clinical-trials-registry/NCT05467722.