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

NCT03947970 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2019-07-24

No results posted yet for this 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

  • Hemodialysis
  • Healthy

Interventions

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)

Sponsors & Collaborators

  • Cara Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Frédérique Menzaghi, PhD · Cara Therapeutics

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-17
Primary Completion
2019-04-06
Completion
2019-04-06
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03947970 on ClinicalTrials.gov