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

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 - Mass balance 14C-radiolabeled cenerimod in healthy volunteers

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42951

Enrollment

Registered

2016-09-13

Start date

2016-09-19

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune disorder SLE

Interventions

The volunteer will receive a single dose of 2 mg/3.7 MBq radiolabeled cenerimod as an oral solution of 25 mL.

14C ADME

Immune disorder

safety

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: healthy male subjects 45-65 yrs, inclusive BMI : 18.0-30.0 kg/m2, inclusive SBP 100-145 mmHg, DBP 50-90 mmHg, and heart rate 55-90 bpm Signed informed consent in a language understandable to the subject prior to any study-mandated procedure. No clinically significant findings on the physical examination at screening. Regular (daily) defecation pattern.

Exclusion criteria

Exclusion criteria: No cardiac significant disorders, no asthma, no chronic obstructive pulmonary disease, no tuberculosis. No HIV, hepatitis B and C. No immunosuppressive treatment within 6 weeks. No other investigational drug within 3 months or not more than 4 studies with investigational drugs within 1 year. No study with a radiation burden of >0.1 mSv and =

Design outcomes

Primary

Measure	Time frame
- Change from baseline to each time point of measurement in vital signs (supine BP and pulse rate) after study treatment administration. - Change from baseline to each time point of measurement in ECG variables: HR, and the intervals: PR, QRS, QT, QTc calculated according to Bazetts correction (QTcB), and QTc calculated according to Fridericias correction (QTcF) after study treatment administration. - Change from baseline to each time point of measurement in clinical laboratory variables after study treatment administration. - Change from baseline to EOS in body weight. - Treatment-emergent ECG abnormalities from study treatment administration up to EOS. - Treatment-emergent AEs from study treatment administration up to EOS. - Treatment-emergent SAEs from study treatment administration up to EOS. - Mass balance (Cumulative excretion of radioactivity in urine, feces, and expired air (if applicable)) - PK of 14C radioactivity in whole blood and plasma. - PK of cenerimod and its metabolites in plasma. - Metabolic profiling (profiles, identification, and quantification of cenerimod metabolites in plasma, urine, and feces).	—

Measure

Time frame

- Change from baseline to each time point of measurement in vital signs (supine BP and pulse rate) after study treatment administration. - Change from baseline to each time point of measurement in ECG variables: HR, and the intervals: PR, QRS, QT, QTc calculated according to Bazett*s correction (QTcB), and QTc calculated according to Fridericia*s correction (QTcF) after study treatment administration. - Change from baseline to each time point of measurement in clinical laboratory variables after study treatment administration. - Change from baseline to EOS in body weight. - Treatment-emergent ECG abnormalities from study treatment administration up to EOS. - Treatment-emergent AEs from study treatment administration up to EOS. - Treatment-emergent SAEs from study treatment administration up to EOS. - Mass balance (Cumulative excretion of radioactivity in urine, feces, and expired air (if applicable)) - PK of 14C radioactivity in whole blood and plasma. - PK of cenerimod and its metabolites in plasma. - Metabolic profiling (profiles, identification, and quantification of cenerimod metabolites in plasma, urine, and feces).

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Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)