Calendario›VTRS›Cenerimod

Cenerimod

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

Ensayo de Viatris Inc en Voluntarios sanos.

Fase

Fase 1

Estado

Completado

Participantes

20

previstos

Centros

1

Fin del objetivo primario

oct 2019

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en ago 2019.

Qué mide

The area under the plasma concentration-time curve (AUC) for cenerimod (From Day 1 to Day 49) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis 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.

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Ficha completa en ClinicalTrials.gov (NCT04052360), actualizada en sep 2025.