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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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.

Key facts

Study ID
NCT04019574
Run by
Cara Therapeutics, Inc.
People needed
57
Starts
2019-06-20
Expected to finish
2019-10-29
Last updated by the study team
2020-02-21

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

Where it is running

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.