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

NCT03951402 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2019-05-17

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Grünenthal GmbH

    lead INDUSTRY

Principal Investigators

  • Grünenthal Study Director · Grünenthal GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
45 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-03-31
Primary Completion
2003-08-31
Completion
2003-08-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03951402 on ClinicalTrials.gov