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.
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.