drugset / Trial / NCT04168723
TQT2 Study to Evaluate the Effect of MD1003 on Cardiac Repolarization in Healthy Adult Subjects
Phase 1
Unknown
64 enrolled
MedDay Pharmaceuticals SA
ERT: Clinical Trial Technology Solutions · collabParexel · collab
RandomizedParallel-groupQuadruple-blindOther
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.
Timeline
- Start
- 2019-11-11
- Primary completion
- 2020-03-05
- Completion
- 2020-03-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Biotin | Small molecule | 1200 mg | — |
| Comparator | Moxifloxacin | Small molecule | 400 mg | — |
Indications
No indication recorded.