NCT03958123

Evaluation of the Effects of Multiple Doses of Cebranopadol on the Electrical Activity of the Heart in Healthy Subjects

Evaluation of the Effects of Multiple Therapeutic and Supratherapeutic Doses of Cebranopadol on Cardiac Repolarization in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 171 (actual)
• Sponsor: Tris Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Prolonged QTc Interval
• Pharmacokinetic

Interventions

Type	Name	Description
DRUG	100 μg cebranopadol	Encapsulated 100 μg cebranopadol tablet.
DRUG	200 μg cebranopadol	Encapsulated 200 μg cebranopadol tablet.
DRUG	400 μg cebranopadol	Encapsulated 400 μg cebranopadol tablet.
DRUG	Placebo to cebranopadol encapsulated tablets	Matching placebo to cebranopadol encapsulated tablet.
DRUG	400 mg Moxifloxacin	Encapsulated 400 mg moxifloxacin tablet.
DRUG	Placebo to moxifloxacin encapsulated tablets	Matching placebo to moxifloxacin (400 mg) encapsulated tablet.

Timeline

• Start date: 2013-07-10
• Primary completion: 2013-11-27
• Completion: 2013-11-27
• First posted: 2019-05-21
• Last updated: 2021-07-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study