Study to Investigate the Effects of Single Intravenous Doses of Difelikefalin (CR845) on the QTc Interval in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: CR845 0.5 mcg/kg IV; Other: Placebo; Drug: Moxifloxacin 400 mg Oral Tablet; Drug: CR845 3 mcg/kg IV

• Registration Number: NCT04019574
• Lead Sponsor: Cara Therapeutics, Inc.

Brief Summary

This is a Phase 1, randomized, double-blind (except for moxifloxacin), placebo- and positive-controlled, single-site, 4-way crossover study to investigate the effects of single therapeutic and supratherapeutic IV doses of difelikefalin (CR845) on the QTc interval in healthy adult subjects. Subjects will be randomized to a treatment sequence consisting of 4 treatment periods with a minimum 5-day washout between treatments. Subjects will receive each of the study treatments over the course of the study. Randomized subjects will receive the assigned study treatment as a single dose in the fasted state in the morning on Day 1 of each treatment period.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-20
• Study First Submitted: 2019-07-08
• Study First Submitted QC: 2019-07-10
• Study First Posted: 2019-07-15
• Primary Completion: 2019-10-22
• Study Completion: 2019-10-29
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-20
• Last Update Posted: 2020-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

• Body weight between 50 to 120 kg and body mass index within 18 to 29 kg/m2 at Screening;
• Current nonsmokers who have not used any tobacco- or nicotine-containing products (chewed or smoked) or replacement products, including, but not limited to, electronic cigarettes, in the 45 days prior to Screening.

Key

Exclusion Criteria

• Past or present diseases, which as judged by the Investigator, may affect the outcome of this study;
• Any condition or situation that, in the opinion of the Investigator, would prevent proper evaluation of the safety or efficacy of the study treatment according to the study protocol;
• History of hypersensitivity or allergy to moxifloxacin or any other study treatment or history of tendonitis or tendon rupture with moxifloxacin or any other quinolone type drug.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CR845 0.5 mcg/kg IV (Therapeutic Dose)	CR845 0.5 mcg/kg IV	-
Placebo IV	Placebo	-
Moxifloxacin 400 mg	Moxifloxacin 400 mg Oral Tablet	-
CR845 3 mcg/kg IV (Supratherapeutic Dose)	CR845 3 mcg/kg IV	-

Primary Outcome Measures

Name	Time	Method
QTc change from baseline following CR845 treatment.	Baseline, Day 1

Secondary Outcome Measures

Name	Time	Method
Change from baseline in QTc with Bazett correction (QTcB).	Baseline, Day 1
Change from baseline in Heart Rate.	Baseline, Day 1

Trial Locations

Locations (1)

Cara Therapeutics Study Site; 🇺🇸 Dallas, Texas, United States