A Study to Evaluate Cenerimod in Healthy Male Subjects

NCT02914223 | Completed Phase 1

• 1 other identifier: AC-064-103
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Subjects

Outcome Measures

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)

  From baseline up to a maximum of 99 days

Secondary Outcomes (9)

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

  From baseline up to a maximum of 99 days

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

  From baseline up to a maximum of 99 days

• t1/2 (terminal half-life)

  From baseline up to a maximum of 99 days

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

  From baseline up to a maximum of 99 days

• Incidence of safety events of interest

  From baseline up to a maximum of 99 days

Study Arms (2)

Treatment and observation period

EXPERIMENTAL

On Day 1, subjects will receive a single oral dose of 2 mg 14C-radiolabeled cenerimod. Subjects will be followed for 21 days during which blood, urine, feces, and expired air samples will be collected

Drug: Cenerimod

Extended observation period

EXPERIMENTAL

In case, radioactivity recovery does not meet the stopping criteria described in the protocol, the subjects will have to come for a maximum of 7 24-h in-clinic visits during which blood, urine, feces, and expired air samples will be collected

Drug: Cenerimod

Interventions

Cenerimod DRUG

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

Extended observation period; Treatment and observation period

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Viatris Innovation GmbH: lead

Study Sites (1)

PRA Health Science

Groningen, 9728 NZ, Netherlands

Location

MeSH Terms

Interventions

cenerimod

Study Officials

• Clinical Trials

  Viatris Innovation GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2016
• First Posted: September 26, 2016
• Study Start: September 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: September 22, 2025

Record last verified: 2018-07

Locations

NL (1)