Clinical trial NCT02914223: A Study to Evaluate Cenerimod in Healthy Male Subjects
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Idorsia Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
First posted: 2016-09-26
Enrollment: 6
Sex: MALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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


Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: From baseline up to a maximum of 99 days
Secondary outcomes:
measure: Cmax (maximum plasma concentration) of 14C-radioactivity in whole blood and plasma
timeFrame: From baseline up to a maximum of 99 days
measure: tmax (time to reach Cmax) of 14C-radioactivity in whole blood and plasma
timeFrame: From baseline up to a maximum of 99 days
measure: t1/2 (terminal half-life)
timeFrame: From baseline up to a maximum of 99 days
measure: Area under the plasma concentration-time curve (AUC) of 14C-radioactivity in whole blood and plasma
timeFrame: From baseline up to a maximum of 99 days
measure: Incidence of safety events of interest
timeFrame: From baseline up to a maximum of 99 days
measure: Number of participants with adverse events (AEs)
timeFrame: From baseline up to a maximum of 99 days
measure: Cenerimod metabolites profiling in plasma
timeFrame: From baseline up to a maximum of 99 days
measure: Cenerimod metabolites profiling in urine
timeFrame: From baseline up to a maximum of 99 days
measure: Cenerimod metabolites profiling in feces
timeFrame: From baseline up to a maximum of 99 days
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: PRA Health Science
Study officials:
affiliation: Actelion
name: Marie-Laure Boof, PhD
role: STUDY_DIRECTOR
References: