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

Study Overview
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: CR845 0.5 mcg/kg IV
* Drug: CR845 3 mcg/kg IV
* Drug: Moxifloxacin 400 mg Oral Tablet
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CR845 0.5 mcg/kg IV (Therapeutic Dose)<br> | Drug: CR845 0.5 mcg/kg IV<br>* 0.5 mcg/kg IV CR845<br>* Other names: Difelikefalin 0.5 mcg/kg;|
| Experimental: CR845 3 mcg/kg IV (Supratherapeutic Dose)<br> | Drug: CR845 3 mcg/kg IV<br>* 3 mcg/kg IV CR845<br>* Other names: Difelikefalin 3 mcg/kg;|
| Placebo Comparator: Placebo IV<br> | Other: Placebo<br>* IV Placebo as a bolus injection<br>|
| Active Comparator: Moxifloxacin 400 mg<br> | Drug: Moxifloxacin 400 mg Oral Tablet<br>* 400 mg Oral Moxifloxacin<br>* Other names: Avelox;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QTc change from baseline following CR845 treatment. |  | Baseline, Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in QTc with Bazett correction (QTcB). |  | Baseline, Day 1 | 
| Change from baseline in Heart Rate. |  | Baseline, Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Difelikefalin, CR845, QTc, TQT