A Study to Evaluate Cenerimod in Healthy Male Subjects

Healthy Subjects Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02914223
• Other study ID #: AC-064-103
• Status: Completed
• Phase: Phase 1
• Start date: September 1, 2016
• Est. completion date: December 1, 2016

Study information

• Verified date: July 2018
• Source: Idorsia Pharmaceuticals Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: December 1, 2016
• Est. primary completion date: December 1, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 45 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

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

Locations

Country	Name	City	State
Netherlands	PRA Health Science	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
Idorsia Pharmaceuticals Ltd.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cmax (maximum plasma concentration) of 14C-radioactivity in whole blood and plasma	Cmax is derived from the observed plasma concentration-time curves	From baseline up to a maximum of 99 days
Secondary	tmax (time to reach Cmax) of 14C-radioactivity in whole blood and plasma	Tmax is derived from the observed plasma concentration-time curves	From baseline up to a maximum of 99 days
Secondary	t1/2 (terminal half-life)		From baseline up to a maximum of 99 days
Secondary	Area under the plasma concentration-time curve (AUC) of 14C-radioactivity in whole blood and plasma	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	From baseline up to a maximum of 99 days
Secondary	Incidence of safety events of interest	Events of interest are any abnormalities in ECG, vital signs or laboratory test results	From baseline up to a maximum of 99 days
Secondary	Number of participants with adverse events (AEs)	Treatment-emergent AEs and treatment emergent serious AEs	From baseline up to a maximum of 99 days
Secondary	Cenerimod metabolites profiling in plasma	Relative abundance expressed as percent of cenerimod	From baseline up to a maximum of 99 days
Secondary	Cenerimod metabolites profiling in urine	Relative abundance expressed as percent of cenerimod	From baseline up to a maximum of 99 days
Secondary	Cenerimod metabolites profiling in feces	Relative abundance expressed as percent of cenerimod	From baseline up to a maximum of 99 days