Status:
COMPLETED
Study to Investigate the Effects of Single Intravenous Doses of Difelikefalin (CR845) on the QTc Interval in Healthy Subjects
Lead Sponsor:
Cara Therapeutics, Inc.
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief 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 suprath...
Eligibility Criteria
Inclusion
- Key
- Body weight between 50 to 120 kg and body mass index within 18 to 29 kg/m2 at Screening;
- Current nonsmokers who have not used any tobacco- or nicotine-containing products (chewed or smoked) or replacement products, including, but not limited to, electronic cigarettes, in the 45 days prior to Screening.
- Key
Exclusion
- Past or present diseases, which as judged by the Investigator, may affect the outcome of this study;
- Any condition or situation that, in the opinion of the Investigator, would prevent proper evaluation of the safety or efficacy of the study treatment according to the study protocol;
- History of hypersensitivity or allergy to moxifloxacin or any other study treatment or history of tendonitis or tendon rupture with moxifloxacin or any other quinolone type drug.
Key Trial Info
Start Date :
June 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 29 2019
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT04019574
Start Date
June 20 2019
End Date
October 29 2019
Last Update
February 21 2020
Active Locations (1)
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1
Cara Therapeutics Study Site
Dallas, Texas, United States, 75247