Study to Evaluate the Pharmacokinetics and Metabolism of [14C] CR845 (Difelikefalin) in Patients With End Stage Renal Disease on Hemodialysis and in Healthy Subjects
Completed · Phase 1
Conditions studied: Hemodialysis, Healthy
In brief
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.
Key facts
- Study ID
- NCT03947970
- Run by
- Cara Therapeutics, Inc.
- People needed
- 12
- Starts
- 2019-01-17
- Expected to finish
- 2019-04-06
- Last updated by the study team
- 2019-07-24
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: accepted.
Where it is running
- Cara Therapeutics Study Site — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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