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

Cara Therapeutics, Inc.1 site in 1 country12 target enrollmentJanuary 17, 2019

ConditionsHemodialysis Healthy

Interventions[14C] CR845

Drugs[14C] CR845

Overview

Phase: Phase 1
Intervention: [14C] CR845
Conditions: Hemodialysis
Sponsor: Cara Therapeutics, Inc.
Enrollment: 12
Locations: 1
Primary Endpoint: Measure of the [14C] CR845 and total radioactivity (total [14C] CR845-equivalents) in plasma, urine, feces, and dialysate will be determined.
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

January 17, 2019

End Date

April 6, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Cara Therapeutics, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•Has a concomitant disease or any medical condition that, in the opinion of the Investigator, could pose undue risk to the patient, impede completion of the study procedures, or would compromise the validity of the study measurements, including, but not limited to:
•Known or suspected history of alcohol, narcotic, or other drug abuse, or substance dependence within 12 months prior to Screening;
•Significant systolic or diastolic heart failure (eg, New York Heart Association Class IV congestive heart failure \[Appendix 1\]);
•Severe mental illness or cognitive impairment (eg, dementia);
•Any other relevant acute or chronic medical or neuropsychiatric condition.
•History of important drug or other allergy (except for untreated, asymptomatic seasonal allergies at time of dosing) unless deemed not clinically significant by the Investigator;
•Use of any beverages and foods containing alcohol, quinine (tonic water), grapefruit, broccoli, Brussels sprouts, Seville oranges, pomegranate, star fruit, char-grilled meat, or caffeine/xanthine from 48 hours prior to dosing with study medication without evaluation and approval by the Investigator;
•Use of any over-the-counter (OTC) medication (including nutritional or dietary supplements, herbal preparations, or vitamins, chapparal, comfrey, germander, gin bu huan, kava, pennyroyal, skullcap, St. John's Wort, or valerian) within 7 days prior to dosing with study medication;
•Use of any new prescription medication from 14 days prior to dosing with study medication without evaluation and approval by the Investigator;
•Has been treated with any known drugs that are moderate or strong inhibitors/inducers of cytochrome P450 (CYP) enzymes (e.g., barbiturates, phenothiazines, cimetidine, carbamazepine) within 30 days prior to dosing with study medication, and that, in the Investigator's judgment, may impact subject safety or the validity of the study results;

Arms & Interventions

[14C] CR845

Subjects will receive a single dose of \[14C\] CR845 IV solution administered as an IV bolus on Day 1.

Intervention: [14C] CR845

Outcomes

Primary Outcomes

Measure of the [14C] CR845 and total radioactivity (total [14C] CR845-equivalents) in plasma, urine, feces, and dialysate will be determined.