TQT2 Study to Evaluate the Effect of MD1003 on Cardiac Repolarization in Healthy Adult Subjects
Status:
Recruiting
Trial end date:
2020-03-05
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
MedDay Pharmaceuticals SA
Collaborators:
ERT: Clinical Trial Technology Solutions Parexel
Treatments:
Moxifloxacin Norgestimate, ethinyl estradiol drug combination