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Completed

NCT Number: NCT02914223

A Study to Evaluate Cenerimod in Healthy Male Subjects

The main objective of the study is to investigate the rate and routes of elimination of cenerimod and the mass balance in urine, feces, and expired air

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Key information

Conditions

Healthy Subjects

Age range

45 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

PRA Health Science

Groningen, 9728 NZ, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed informed consent in a language understandable to the subject prior to any study-mandated procedure
  • Healthy male subjects aged between 45 and 65 years (inclusive) at screening
  • No clinically significant findings on the physical examination at screening
  • Body mass index (BMI) of 18.0 to 30.0 kg/m2 (inclusive) at screening
  • Systolic blood pressure (SBP) 100-145 mmHg and diastolic blood pressure (DBP) 50-90 mmHg, measured on either arm, after 5 min in the supine position at screening and at Day 1 pre-dose
  • Heart rate (HR) 55-90 bpm (inclusive) measured with 12-lead ECG after 5 min in the supine position at screening and at Day 1 pre-dose

Exclusion criteria

  • Known hypersensitivity to cenerimod or to S1P receptor modulators, or to any excipients of the cenerimod drug formulation
  • History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism, or excretion of the study treatment (appendectomy and herniotomy allowed, cholecystectomy not allowed)
  • History or clinical evidence suggestive of active or latent tuberculosis including a positive QuantiFERON®-TB test at screening
  • Any cardiac condition or illness (including 12-lead ECG abnormalities) with a potential to increase the cardiac risk of the subject based on the standard 12-lead ECG at screening and at Day 1 pre-dose
  • Participation in another study with a radiation burden of > 0.1 mSv and ≤ 1 mSv in the period of 1 year prior to screening; a radiation burden of ≥ 1.1 mSv and ≤ 2 mSv in the period of 2 years prior to screening, etc. (add 1 year per 1 mSv)
  • Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol
  • Any immunosuppressive treatment within 6 weeks or within 5 elimination half-lives of the immunosuppressive treatment, whichever is longer, before study treatment administration

Treatment and study plan

Cenerimod

Drug

Oral formulation of cenerimod (2mg) containing 100 μCi (3.7 MBq) of 14C-radiolabeled cenerimod

Primary outcomes

  1. Cumulative excretion calculated by summing up the daily radioactivity excretion measured by means of liquid scintillation counting in urine, feces, and expired air (if applicable)

    Time frame: From baseline up to a maximum of 99 days

Secondary outcomes

  1. Cmax (maximum plasma concentration) of 14C-radioactivity in whole blood and plasma

    Time frame: From baseline up to a maximum of 99 days

    Cmax is derived from the observed plasma concentration-time curves

  2. tmax (time to reach Cmax) of 14C-radioactivity in whole blood and plasma

    Time frame: From baseline up to a maximum of 99 days

    Tmax is derived from the observed plasma concentration-time curves

  3. t1/2 (terminal half-life)

    Time frame: From baseline up to a maximum of 99 days

  4. Area under the plasma concentration-time curve (AUC) of 14C-radioactivity in whole blood and plasma

    Time frame: From baseline up to a maximum of 99 days

    AUC is defined for the time intervals from zero to time t of the last measured concentration above the limit of quantification and from zero to infinity

  5. Incidence of safety events of interest

    Time frame: From baseline up to a maximum of 99 days

    Events of interest are any abnormalities in ECG, vital signs or laboratory test results

  6. Number of participants with adverse events (AEs)

    Time frame: From baseline up to a maximum of 99 days

    Treatment-emergent AEs and treatment emergent serious AEs

  7. Cenerimod metabolites profiling in plasma

    Time frame: From baseline up to a maximum of 99 days

    Relative abundance expressed as percent of cenerimod

  8. Cenerimod metabolites profiling in urine

    Time frame: From baseline up to a maximum of 99 days

    Relative abundance expressed as percent of cenerimod

  9. Cenerimod metabolites profiling in feces

    Time frame: From baseline up to a maximum of 99 days

    Relative abundance expressed as percent of cenerimod

Sponsors and collaborators

Lead sponsor

Viatris Innovation GmbH

Industry

Registry information

Official study title

Single-center, Open-label Study With 14C-radiolabeled Cenerimod to Investigate the Mass Balance, Pharmacokinetics, and Metabolism Following Single Oral Administration to Healthy Male Subjects

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Sep 26, 2016
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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