Concert Pharmaceuticals is starting a new clinical trial of Study to Assess the Effect of Renal Impairment on the Pharmacokinetics of CTP-543.
This is an open-label, single-dose, sequentially designed, single-period study to determine the effect of moderate renal 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 clinical trial started in June 6, 2022 and will continue throughout September 2022.
Single dose PK exposure: Area Under the Concentration-Time Curve from time zero to the time of the last observed/measured non-zero concentration (AUC0-t) will be primary outcome measure. Area under the concentration-time curve from time zero (pre-dose) to time of last measurable concentration (calculated by linear-log trapezoidal summation).
For more details: https://ichgcp.net/clinical-trials-registry/NCT05468749.