Pharmacokinetic Clinical Trial
Official title:
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
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.
n/a
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