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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04019574

Enrollment

Registered

2019-07-15

Start date

2019-06-20

Completion date

2019-10-29

Last updated

2020-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Difelikefalin, CR845, QTc, TQT

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.

Interventions

DRUGCR845 0.5 mcg/kg IV

0.5 mcg/kg IV CR845

DRUGCR845 3 mcg/kg IV

3 mcg/kg IV CR845

DRUGMoxifloxacin 400 mg Oral Tablet

400 mg Oral Moxifloxacin

OTHERPlacebo

IV Placebo as a bolus injection

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

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.

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026