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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-20

Study Completion Date

2019-10-29

Brief Summary

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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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Safety Issues

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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CR845 0.5 mcg/kg IV (Therapeutic Dose)

Group Type EXPERIMENTAL

CR845 0.5 mcg/kg IV

Intervention Type DRUG

0.5 mcg/kg IV CR845

CR845 3 mcg/kg IV (Supratherapeutic Dose)

Group Type EXPERIMENTAL

CR845 3 mcg/kg IV

Intervention Type DRUG

3 mcg/kg IV CR845

Placebo IV

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

IV Placebo as a bolus injection

Moxifloxacin 400 mg

Group Type ACTIVE_COMPARATOR

Moxifloxacin 400 mg Oral Tablet

Intervention Type DRUG

400 mg Oral Moxifloxacin

Interventions

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CR845 0.5 mcg/kg IV

0.5 mcg/kg IV CR845

Intervention Type DRUG

CR845 3 mcg/kg IV

3 mcg/kg IV CR845

Intervention Type DRUG

Moxifloxacin 400 mg Oral Tablet

400 mg Oral Moxifloxacin

Intervention Type DRUG

Placebo

IV Placebo as a bolus injection

Intervention Type OTHER

Other Intervention Names

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Difelikefalin 0.5 mcg/kg Difelikefalin 3 mcg/kg Avelox

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes