Overview

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

Status:
Completed

Trial end date:
2019-10-29

Target enrollment:

Participant gender:

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.

Phase:

Phase 1

Details

Lead Sponsor:

Cara Therapeutics, Inc.

Treatments:

Moxifloxacin
Norgestimate, ethinyl estradiol drug combination