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

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2019
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.
Epistemonikos ID: 188da86aa1e2af80c2bd5383d37eb4bbb651e003
First added on: May 22, 2024