A Study to Evaluate Cenerimod in Healthy Male Subjects

Viatris Innovation GmbH

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: Cenerimod

Study type: Interventional

Funder types: Industry

Identifiers

NCT02914223

AC-064-103

Details and patient eligibility

About

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

Enrollment: 6 patients

Sex: Male

Ages: 45 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 2 patient groups

Treatment and observation period

Experimental group

Description:

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

Treatment:

Drug: Cenerimod

Extended observation period

Experimental group

Description:

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

Treatment:

Drug: Cenerimod