Healthy Volunteers Clinical Trial
Official title:
A Phase 1, Single-Center, Double-Blind, Randomized, Placebo- and Positive Controlled, Double-Dummy, Parallel-Group, Repeated Dose Study With a Nested Cross-Over Comparison Between Moxifloxacin and Placebo to Evaluate the Effect of MD1003 on Cardiac Repolarization in Healthy Adult Subjects
This is a Phase 1, single-center, double-blind, randomized, placebo- and positive controlled,
double-dummy, parallel-group, repeated-dose study with a nested cross-over comparison between
moxifloxacin and placebo to evaluate the effect of MD1003 on cardiac repolarization in
healthy adult subjects.
The planned enrollment is approximately 64 subjects randomized in a ratio of 1:1 to 2main
groups. Subjects in Group B will be further randomized to Subgroups B1 and B2 in a ratio of
1:1.
This study is designed as a definitive evaluation of the potential of MD1003 and its major
metabolites to have a threshold effect on cardiac repolarization, as detected by QT/QTc
prolongation. The design is aligned with the recommendations for evaluation of QT/QTc
interval prolongation outlined in the International Council for Harmonization (ICH) E14
guidance.
This is a Phase 1, single-center, double-blind, randomized, placebo- and positive controlled,
double-dummy, parallel-group, repeated-dose study with a nested cross-over comparison between
moxifloxacin and placebo to evaluate the effect of MD1003 on cardiac repolarization in
healthy adult subjects.
A total of 64 subjects will be enrolled in the clinical study according to the
inclusion/exclusion criteria. The study consists of two main groups with 32 subjects per dose
group. All subjects will receive placebo for MD1003 on Day -1. Subjects in Group A will
receive MD1003 (biotin) 1200 mg and placebo for moxifloxacin on Day 1, MD1003 (biotin) 1200
mg from Day 2 through Day 8 and placebo for moxifloxacin on Day 9. Subjects in Group B will
be further randomized to Subgroup B1 (16 subjects) receiving moxifloxacin 400 mg and placebo
for MD1003 on Day 1, placebo for MD1003 from Day 2 through Day 8 and placebo for moxifloxacin
on Day 9. Subgroup B2 (16 subjects) will receive placebo for moxifloxacin and placebo for
MD1003 on Day 1, placebo for MD1003 from Day 2 through Day 8 and moxifloxacin 400 mg on Day
9.
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