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

NCT04019574 | Completed Phase 1 FDA Drug

• 1 other identifier: CR845-100201
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Difelikefalin; CR845; QTc; TQT

Outcome Measures

Primary Outcomes (1)

• QTc change from baseline following CR845 treatment.

  Baseline, Day 1

Secondary Outcomes (2)

• Change from baseline in QTc with Bazett correction (QTcB).

  Baseline, Day 1

• Change from baseline in Heart Rate.

  Baseline, Day 1

Study Arms (4)

CR845 0.5 mcg/kg IV (Therapeutic Dose)

EXPERIMENTAL

Drug: CR845 0.5 mcg/kg IV

CR845 3 mcg/kg IV (Supratherapeutic Dose)

EXPERIMENTAL

Drug: CR845 3 mcg/kg IV

Placebo IV

PLACEBO COMPARATOR

Other: Placebo

Moxifloxacin 400 mg

ACTIVE COMPARATOR

Drug: Moxifloxacin 400 mg Oral Tablet

Interventions

CR845 0.5 mcg/kg IV DRUG

0.5 mcg/kg IV CR845

Also known as: Difelikefalin 0.5 mcg/kg

CR845 0.5 mcg/kg IV (Therapeutic Dose)

CR845 3 mcg/kg IV DRUG

3 mcg/kg IV CR845

Also known as: Difelikefalin 3 mcg/kg

CR845 3 mcg/kg IV (Supratherapeutic Dose)

Moxifloxacin 400 mg Oral Tablet DRUG

400 mg Oral Moxifloxacin

Also known as: Avelox

Moxifloxacin 400 mg

Placebo OTHER

IV Placebo as a bolus injection

Placebo IV

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cara Therapeutics, Inc.: lead

Study Sites (1)

Cara Therapeutics Study Site

Dallas, Texas, 75247, United States

Location

MeSH Terms

Interventions

difelikefalin; Moxifloxacin; Tablets

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Frédérique Menzaghi, PhD

  Cara Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2019
• First Posted: July 15, 2019
• Study Start: June 20, 2019
• Primary Completion: October 22, 2019
• Study Completion: October 29, 2019
• Last Updated: February 21, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)