NCT03947970

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

A Phase 1, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics and Metabolism of [14C] CR845 in Patients With End Stage Renal Disease on Hemodialysis and in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Cara Therapeutics, Inc. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a Phase 1, open-label, single-radiolabeled dose, non-randomized study in 6 male patients on HD and 6 healthy male subjects. The study will consist of a Screening Period, a Study Period, and an End-of-Study assessment.

Conditions

• Hemodialysis
• Healthy

Interventions

Type	Name	Description
DRUG	[14C] CR845	Subjects will receive a single dose of 230 mcg CR845 solution containing 100 microcuries \[14C\] CR845, administered via IV bolus (the total dose of CR845 will range from 1.7 to 3.1 mcg/kg)

Timeline

• Start date: 2019-01-17
• Primary completion: 2019-04-06
• Completion: 2019-04-06
• First posted: 2019-05-13
• Last updated: 2019-07-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study