Evaluation of the Effects of Multiple Doses of Cebranopadol on the Electrical Activity of the Heart in Healthy Subjects
Status:
Completed
Trial end date:
2013-11-27
Target enrollment:
Participant gender:
Summary
The objective of this study was to evaluate the effects of cebranopadol (GRT6005) on the
electrical activity of the heart in healthy participants.
The study consisted of a screening period within 21 days before the first dose of
investigational medicinal product (IMP) (between Day -25 and Day -4) during which informed
consent was obtained and the general suitability of the participants for the trial was
assessed according to the inclusion/exclusion criteria.
Participants were confined to the trial site from 4 days before first IMP dosing on Day 1 to
4 days after last IMP dosing on Day 30. During this period, multiple-doses of cebranopadol or
matching placebo and a single-dose of moxifloxacin or matching placebo were administered.
Moxifloxacin was used as a positive control. It has consistently shown that it has an effect
on the heart rhythm. Continuous 12-lead ECGs were recorded at defined time points. Multiple
blood and urine samples were drawn for pharmacokinetic evaluations and safety laboratory
monitoring (hematology, chemistry, and urinalysis). Additional safety evaluations included
recording of adverse events, vital signs (systolic and diastolic blood pressure, pulse rate,
respiration rate, body temperature, and weight), oxygen saturation, standard 12-lead ECG,
Clinical Opiate Withdrawal Scale (COWS) assessment, and Columbia-Suicide Severity Rating
Scale (C-SSRS) assessment.
An End-of-Trial Visit was performed on Day 34, or within 7 days after the last
pharmacokinetic sample on Day 34, or at early withdrawal.
Phase:
Phase 1
Details
Lead Sponsor:
Grünenthal GmbH Tris Pharma, Inc.
Collaborator:
Forest Laboratories
Treatments:
Moxifloxacin Norgestimate, ethinyl estradiol drug combination