NCT03951402

Effect of a Multiple-dose Oral Administration of CG5503 PR on the Electrical Activity of the Heart in 48 Healthy Men and Women

Investigation of the Effect on the QT/QTc Interval After Multiple Dose Oral Administration (100 and 200 mg Bid) of CG5503 PR in a Randomised, Double-blind, Double-dummy Placebo- and Moxifloxacin-controlled 4- Way Cross-over Phase I Study in 48 Healthy Male and Female Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Grünenthal GmbH · Industry
• Sex: All
• Age: 45 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The effect of multiple oral administration of two doses of CG5503 PR (prolonged release) compared to placebo on the electrical activity of the heart were investigated. The rationale to perform this study was to exclude any effect of CG5503 on the heart rhythm. This study was a randomised, double-blind, double-dummy, placebo- and moxifloxacin-controlled, 4-way cross-over study. Participants were given a combination of either CG5503 PR and placebo (medication with inactive ingredients which looks like the study drug) or moxifloxacin and placebo. Moxifloxacin was used as a positive control. It has consistently shown that it has an effect on the heart rhythm. Within 14 days prior to the first dosing, participants had a physical examination, a 12-lead electrocardiogram (ECG) was recorded and haematological, serological, biochemical, and urine analyses took place. A blood sample for optional genotyping of genes responsible for long QT syndrome was taken. During each dosing session, the participants were confined in the evening before baseline assessments were performed and stayed in the clinic until 48 hours after the last dosing. Study medication was administered on Day 1 and 2 in the morning (0.5 hours after breakfast) and in the evening (1.5 hours after dinner), and on Day 3 in the morning (0.5 hours after breakfast). Dosing was separated by at least 7 days between the last dosing of each period and the first dosing of next period. Interim analysis of ECG-data were performed after completion of 24 participants (group 1) with possible subsequent adjustment of sample size for group 2.

Conditions

• Prolonged QTc Interval
• Pharmacokinetic

Interventions

Type	Name	Description
DRUG	100 mg CG5503 (tapentadol hydrochloride) PR tablet	100 mg CG5503 (tapentadol hydrochloride) PR tablet.
DRUG	Placebo matching CG5503 PR tablet	Matching placebo tablet to CG5503 PR tablet.
DRUG	Placebo matching moxifloxacin capsule	Matching placebo capsule to moxifloxacin capsule.
DRUG	400 mg Moxifloxacin tablet (overencapsulated)	Overencapsulated 400 mg Moxifloxacin tablet.

Timeline

• Start date: 2003-03-01
• Primary completion: 2003-08-01
• Completion: 2003-08-01
• First posted: 2019-05-15
• Last updated: 2019-05-17

Locations

1 site across 1 country: Germany