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Clinical Trial Details

Trial ID: L1637
Source ID: NCT03947970
Associated Drug: [14c] Cr845
Title: Study to Evaluate the Pharmacokinetics and Metabolism of [14C] CR845 (Difelikefalin) in Patients With End Stage Renal Disease on Hemodialysis and in Healthy Subjects
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Hemodialysis|Healthy
Interventions: DRUG: [14C] CR845
Outcome Measures: Primary: Measure of the [14C] CR845 and total radioactivity (total [14C] CR845-equivalents) in plasma, urine, feces, and dialysate will be determined., Day 1 to up to 7 days post dose in healthy volunteers and Day 1 to up to 14 days post dose in patients on HD|Extent of recovery of [14C] CR845 and radioactivity related to [14C] CR845 in plasma, urine, feces, and dialysate, as applicable, will be derived., Day 1 to up to 7 days post dose in healthy volunteers and Day 1 to up to 14 days post dose in patients on HD|Cumulative amount of [14C] CR845 and [14C] CR845-equivalents in urine and feces over the collection period will be calculated., Day 1 to up to 7 days post dose in healthy volunteers and Day 1 to up to 14 days post dose in patients on HD|Presence of possible CR845 metabolites will be assessed., Day 1 to up to 7 days post dose in healthy volunteers and Day 1 to up to 14 days post dose in patients on HD|Quantitation of possible CR845 metabolites will be assessed., Day 1 to up to 7 days post dose in healthy volunteers and Day 1 to up to 14 days post dose in patients on HD | Secondary: Frequency and severity of adverse events by treatment group, Day 1 to up to 7 days post dose in healthy volunteers and Day 1 to up to 14 days post dose in patients on HD
Sponsor/Collaborators: Sponsor: Cara Therapeutics, Inc.
Gender: MALE
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 12
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2019-01-17
Completion Date: 2019-04-06
Results First Posted:
Last Update Posted: 2019-07-24
Locations: Cara Therapeutics Study Site, San Antonio, Texas, 78217, United States
URL: https://clinicaltrials.gov/show/NCT03947970