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.

A Single-center, Double-blind for Cenerimod, Open-label for Moxifloxacin, Placebo-controlled, Parallel-group, Randomized Study in Healthy Male and Female Subjects to Investigate I: the Effect of Cenerimod on the QTc Interval II: the Effect of Cenerimod on the Pharmacokinetics of Combined Oral Contraceptives III: the Effect of Charcoal on the Pharmacokinetics of Cenerimod.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: Viatris Innovation GmbH · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

Participants randomized in one of the cenerimod or placebo groups will receive combined oral contraceptives on Day 1 (i.e., prior to cenerimod or placebo administration, Period 1) and on Day 42 (i.e., 36 days after the stat of cenerimod or placebo, Period 2). Half of the participants randomized in one of the cenerimod or placebo groups will be enrolled in an accelerated elimination procedure part (Period 3).

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-01-31
• Primary completion: 2021-09-14
• Completion: 2021-10-18
• First posted: 2020-02-05
• Last updated: 2025-09-22

Locations

1 site across 1 country: France