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NCT03947970 · ClinicalTrials.gov registry record · Phase 1
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 study of Healthy and Hemodialysis, sponsored by Cara Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT03947970 is a Phase 1 study of Healthy and Hemodialysis that has completed, run by Cara Therapeutics. The registered enrollment target is 12 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03947970, a Phase 1 study of Healthy and Hemodialysis, has completed, sponsored by Cara Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG [14C] CR845
Study Locations (1)
Texas
- Cara Therapeutics Study Site - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2019-01-17 |
| Est. Completion | 2019-04-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03947970
The ClinicalTrials.gov registry entry for NCT03947970 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (98% lower). The listed sponsor is Cara Therapeutics, which has 23 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Healthy appearing as the primary indexed condition, and to 1 intervention - of which [14C] CR845 is the first listed.
NCT03947970 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT03947970 about?
NCT03947970 is a clinical study titled "Study to Evaluate the Pharmacokinetics and Metabolism of [14C] CR845 (Difelikefalin) in Patients With End Stage Renal Disease on Hemodialysis and in Healthy Subjects". 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 ...
What is the current status of trial NCT03947970?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2019-01-17. Estimated completion is 2019-04-06.
What conditions does trial NCT03947970 study?
This clinical trial studies the following conditions: Healthy, Hemodialysis.
What interventions are being tested in trial NCT03947970?
The interventions under investigation include: [14C] CR845 (DRUG).
Who is sponsoring clinical trial NCT03947970?
This trial is sponsored by Cara Therapeutics, which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03947970 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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