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

A Randomized, Double-Blind, Placebo- and Positive-Controlled, Four-way Crossover Study to Investigate the Effects of Single Intravenous Doses of Difelikefalin (CR845) on the QTc Interval in Healthy Subjects

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75247
      • Cara Therapeutics Study Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Moxifloxacin 400 mg	Drug: Moxifloxacin 400 mg Oral Tablet; 400 mg Oral Moxifloxacin; Other Names: Avelox
Placebo Comparator: Placebo IV	Other: Placebo; IV Placebo as a bolus injection
Experimental: CR845 0.5 mcg/kg IV (Therapeutic Dose)	Drug: CR845 0.5 mcg/kg IV; 0.5 mcg/kg IV CR845; Other Names: Difelikefalin 0.5 mcg/kg
Experimental: CR845 3 mcg/kg IV (Supratherapeutic Dose)	Drug: CR845 3 mcg/kg IV; 3 mcg/kg IV CR845; Other Names: Difelikefalin 3 mcg/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
QTc change from baseline following CR845 treatment.	Baseline, Day 1

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in QTc with Bazett correction (QTcB).	Baseline, Day 1
Change from baseline in Heart Rate.	Baseline, Day 1

Collaborators and Investigators

• Sponsor: Cara Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2019
• Primary Completion (Actual): October 22, 2019
• Study Completion (Actual): October 29, 2019

Study Registration Dates

• First Submitted: July 8, 2019
• First Submitted That Met QC Criteria: July 10, 2019
• First Posted (Actual): July 15, 2019

Study Record Updates

• Last Update Posted (Actual): February 21, 2020
• Last Update Submitted That Met QC Criteria: February 20, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: TQT; QTc; Difelikefalin; CR845
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Moxifloxacin
• Other Study ID Numbers: CR845-100201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No