NCT04019574

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Cara Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	CR845 0.5 mcg/kg IV	0.5 mcg/kg IV CR845
DRUG	CR845 3 mcg/kg IV	3 mcg/kg IV CR845
DRUG	Moxifloxacin 400 mg Oral Tablet	400 mg Oral Moxifloxacin
OTHER	Placebo	IV Placebo as a bolus injection

Timeline

• Start date: 2019-06-20
• Primary completion: 2019-10-22
• Completion: 2019-10-29
• First posted: 2019-07-15
• Last updated: 2020-02-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study