NCT04168723

TQT2 Study to Evaluate the Effect of MD1003 on Cardiac Repolarization in Healthy Adult Subjects

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: MedDay Pharmaceuticals SA · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	MD1003	Group A: Daily dose of 1200 mg of MD1003 from Day 1 to Day 8
DRUG	Moxifloxacin 400mg	Group B1: Moxifloxacin 400 mg on Day 1 Group B2: Moxifloxacin 400 mg on Day 9
DRUG	Placebo for MD1003	Group A: Placebo for MD1003 on Day -1 Group B1: Placebo for MD1003 on Day -1 Group B2: Placebo for MD1003 on Day -1
DRUG	Placebo for moxifloxacin	Group A: Placebo for moxifloxacin on Day 1 and Day 9 Group B1: Placebo for moxifloxacin on Day 9 Group B2: Placebo for moxifloxacin on Day 1

Timeline

• Start date: 2019-11-11
• Primary completion: 2020-03-05
• Completion: 2020-03-05
• First posted: 2019-11-19
• Last updated: 2020-02-20

Locations

1 site across 1 country: United Kingdom