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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
57
0.5 mcg/kg IV CR845
3 mcg/kg IV CR845
400 mg Oral Moxifloxacin
IV Placebo as a bolus injection
Cara Therapeutics Study Site
Dallas, Texas, United States
QTc change from baseline following CR845 treatment.
Time frame: Baseline, Day 1
Change from baseline in QTc with Bazett correction (QTcB).
Time frame: Baseline, Day 1
Change from baseline in Heart Rate.
Time frame: Baseline, Day 1
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