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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 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2025-09-22

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Viatris Innovation GmbH

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Viatris Innovation GmbH

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04255277 on ClinicalTrials.gov