Study to Evaluate the Pharmacokinetics and Metabolism of [14C] CR845 (Difelikefalin) in Patients With End Stage Renal Disease on Hemodialysis and in Healthy Subjects

Phase 1 Completed 12 enrolled Cara Therapeutics, Inc.

NaSingle-groupOpen-labelOther

Summary

The objectives of this study are to evaluate the in vivo metabolite profiling and characterization of CR845 administered intravenously (IV) in patients on hemodialysis (HD) and in healthy subjects; and to determine the pharmacokinetics of radiolabeled \[14C\] CR845 administered as a single IV bolus in patients on HD and in healthy subjects.

Timeline

Start: 2019-01-17
Primary completion: 2019-04-06
Completion: 2019-04-06

Publications

Stark JG, Noonan PK, Spencer RH, Bhaduri S, O'Connor SJ, Menzaghi F. Pharmacokinetics, Metabolism, and Excretion of Intravenous [14C]Difelikefalin in Healthy Subjects and Subjects on Hemodialysis. Clin Pharmacokinet. 2023 Sep;62(9):1231-1241. doi: 10.1007/s40262-023-01262-2. Epub 2023 Jun 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Difelikefalin	Protein / enzyme biologic	230 ug	Intravenous

Indications

No indication recorded.