A Phase I Study to Evaluate the Absolute Bioavailability of Cenerimod in Healthy Male Volunteers
- Trial ID
- 2025-522320-27-00
- Protocol
- ID-064-108
- Sponsor
- Viatris Innovation GmbH
Trial statistics
Objectives
The primary objective of this study is to evaluate the absolute bioavailability of cenerimod in healthy male participants. Determination of this parameter is essential for characterizing the systemic exposure and absorption profile of the investigational product. This study is categorized under pharmacokinetics (6).
Participants
The sponsor did not provide information regarding the total number of participants. The study population consists of healthy volunteers who are male. Participants fall within specific age ranges categorized as 3 and 4.
Plans and Procedures
This Phase 1 clinical trial is designed as a study to evaluate the absolute bioavailability of cenerimod in healthy male participants. The research methodology follows a specific sequence of study visits. An initial screening visit is conducted to assess eligibility. Subsequent follow-up visits are scheduled to monitor the pharmacological profile, concluding with an end-of-study visit. The total duration of participant involvement is determined by the protocol-defined observation period. Early termination of participation may occur based on predefined clinical criteria or safety considerations.
Treatment
Efficacy
This study involves healthy volunteers in a Phase 3 clinical trial.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
The Netherlands | Not Recruiting | 20 Nov 2025 | — |
Netherlands | — | — | 6 |

