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

Cara Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: CR845 0.5 mcg/kg IV; Other: Placebo; Drug: CR845 3 mcg/kg IV; Drug: Moxifloxacin 400 mg Oral Tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT04019574

CR845-100201

Details and patient eligibility

About

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.

Enrollment: 57 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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57 participants in 4 patient groups, including a placebo group

CR845 0.5 mcg/kg IV (Therapeutic Dose)

Experimental group

Treatment:

Drug: CR845 0.5 mcg/kg IV

CR845 3 mcg/kg IV (Supratherapeutic Dose)

Experimental group

Treatment:

Drug: CR845 3 mcg/kg IV

Placebo IV

Placebo Comparator group

Treatment:

Other: Placebo

Moxifloxacin 400 mg

Active Comparator group

Treatment:

Drug: Moxifloxacin 400 mg Oral Tablet