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Single Oral Dose of 4 mg Cenerimod in Healthy Japanese and Caucasian Subjects

NCT04052360 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-09-22

No results posted yet for this study

Summary

This study is for research purposes only and is not intended to treat any medical condition. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of cenerimod following a single dose in healthy Japanese and Caucasian participants. Pharmacokinetics is the study of the absorption and breakdown of the study drug in the body. Pharmacodynamics is the study of the effect of the study drug on the body. There will be 2 groups in the study. 10 Japanese participants in one group and 10 Caucasian participants in the other group.

The duration of participation in this study is approximately 75 days from screening to the end of study visit. A screening visit is required within 21 days prior to the start of the study to determine whether the volunteer qualifies and is willing to participate in this research study. This study requires in-patient stay in the research clinic of 4 days (3 nights) followed by outpatient visits and an end of study visit 3 to 5 days after the day 49 outpatient visit.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Cenerimod

A single oral dose of 4 mg cenerimod will be administered as a film-coated tablet in the morning of Day 1 under fasted conditions.

DRUG

Matching Placebo

A single oral dose of matching placebo will be administered as a film-coated tablet in the morning of Day 1 under fasted conditions.

Sponsors & Collaborators

  • Viatris Innovation GmbH

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Viatris Innovation GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-08-07
Primary Completion
2019-10-29
Completion
2019-11-02
FDA Drug
Yes

Countries

  • United States

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 NCT04052360 on ClinicalTrials.gov