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NCT Number: NCT04019574

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.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cara Therapeutics Study Site

Dallas, Texas, 75247, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CR845 0.5 mcg/kg IV

Drug

0.5 mcg/kg IV CR845

Other names: Difelikefalin 0.5 mcg/kg

CR845 3 mcg/kg IV

Drug

3 mcg/kg IV CR845

Other names: Difelikefalin 3 mcg/kg

Moxifloxacin 400 mg Oral Tablet

Drug

400 mg Oral Moxifloxacin

Other names: Avelox

Placebo

Other

IV Placebo as a bolus injection

Primary outcomes

  1. QTc change from baseline following CR845 treatment.

    Time frame: Baseline, Day 1

Secondary outcomes

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

    Time frame: Baseline, Day 1

  2. Change from baseline in Heart Rate.

    Time frame: Baseline, Day 1

Sponsors and collaborators

Lead sponsor

Cara Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 15, 2019
Registry last updated
Feb 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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