drugset / Trial / NCT04255277

To Study the Effect of Cenerimod on the Electrical Activity of the Heart, in Men and Women. To Study the Effect of Cenerimod on the Use of Oral Contraceptives in Women. To Study the Effect That Charcoal Has on the Elimination of Cenerimod From the Body, in Women and Men.

NCT04255277

Phase 1 Completed 97 enrolled Viatris Innovation GmbH
RandomizedParallel-groupQuadruple-blindOther

Summary

This is a single-center, randomized, double-blind for cenerimod, open-label for moxifloxacin, placebo- and moxifloxacin-controlled, parallel-group study to investigate the effect of cenerimod on the duration of the QT interval in healthy male and female participants. Participants will be randomly assigned to one of the 4 treatments: placebo, cenerimod 0.5 mg, cenerimod 4 mg or moxifloxacin.

Timeline

Start
2020-01-31
Primary completion
2021-09-14
Completion
2021-10-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Cenerimod Small molecule 0.5 mg Oral
Subject Cenerimod Small molecule 4 mg Oral
Subject Levonorgestrel Small molecule 0.1 mg Oral
Subject Moxifloxacin Small molecule 400 mg Oral
Subject ethinyl estradiol Small molecule 0.02 mg Oral

Indications

No indication recorded.