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Trial · Interventional

CompletedPhase 1Registry data

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

NCTNCT04019574 (opens ClinicalTrials.gov in a new tab)Other idCR845-100201
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
57 participants (actual)
Sponsor
Cara Therapeutics, Inc. · Industry
Design
Randomized · Double masking
Countries
1 country

United States

Start
20 Jun 2019
Primary completion
22 Oct 2019
Completion
29 Oct 2019
First posted
15 Jul 2019
Last update posted
21 Feb 2020
Conditions
Healthy

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20192020
  1. Ph 1

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

    NCT04019574

    20 Jun 2019 to 29 Oct 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • CR845 0.5 mcg/kg IVDrug
  • CR845 3 mcg/kg IVDrug
  • Moxifloxacin 400 mg Oral TabletDrug
  • PlaceboOther

Arms4

  • Experimental

    CR845 0.5 mcg/kg IV (Therapeutic Dose)

  • Experimental

    CR845 3 mcg/kg IV (Supratherapeutic Dose)

  • Placebo comparator

    Placebo IV

  • Active comparator

    Moxifloxacin 400 mg

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. QTc change from baseline following CR845 treatment.

    Time frame · Baseline, Day 1

Secondary outcomes(2)

  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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 45 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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.

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