NCT04255277View on ClinicalTrials.gov

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.

PHASE1CompletedINTERVENTIONAL
Enrollment

97

Participants

Timeline

Start Date

January 31, 2020

Primary Completion Date

September 14, 2021

Study Completion Date

October 18, 2021

Conditions
Healthy Subjects
Interventions
DRUG

Combined oral contraceptives (COC)

A commercially available COC consisting of 0.1mg levonorgestrel and 0.02 mg ethinylestradiol will be used and administered open-label.

DRUG

Moxifloxacin 400mg

A commercially available formulation of moxifloxacin 400 mg will be used and administered open-label. All tablets will be from the same batch.

DRUG

Cenerimod 0.5 mg

This will be administered orally as a film-coated tablet in the morning.

DRUG

Cenerimod 4 mg

This will be administered orally as a film-coated tablet in the morning.

OTHER

Charcoal, activated

Granules for oral suspension will be used and administered open-label.

DRUG

Matching Placebo

Cenerimod matching placebo tablets will be administered once daily orally in the morning.

Trial Locations (1)

35042

Site 1, Rennes

All Listed Sponsors
lead

Viatris Innovation GmbH

INDUSTRY

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. | Biotech Hunter | Biotech Hunter