Interventional, open-label study investigating the absorption, metabolism and excretion (AME) of the research medication following a single oral dose of the 14C-labeled research medication to healthy men

The research medication is a new medication under development for the treatment
of diseases related to the central nervous system (CNS).

-to investigate the mass balance following a single oral dose of 14C-labeled
research medication
-to investigate the pharmacokinetics of total radioactivity in plasma and whole
blood
-to investigate and quantitate metabolites of the research medication (reported
separately)
-to investigate the pharmacokinetics of the research medication and the
metabolite
-to investigate the safety and tolerability of a single dose of the research
medication in healthy men

This is an interventional, open-label study investigating the absorption,
metabolism and excretion (AME) of the research medication following a single
oral dose of the 14C-labeled research medication to healthy men

The study will start with a screening. At the screening a physical examination
will take place and a few other standard medical assessments will be performed
(ECG, vital signs). Furthermore a blood and urine sample will be taken for
laboratory tests and an alcohol breath test and drug screen will be done.

During the stay in the clinic the subject will receive 14C-labeled research
medication once on Day 1. On several time points blood will be taken and feces
and urine will be collected. The subjects will be asked for possible side
effects on regular basis. Furthermore several safety assessments will be done
frequently.

On ambulant visits a blood, urine and feces sample will be taken.

Finally, a follow-up visit will take place.

Two clinical studies with the research medication have been conducted, one
study in healthy volunteers and one in patients with schizophrenia. No serious
adverse events were reported in both studies.

In the study with healthy volunteers all AEs were of mild intensity and short
duration. The AE's in patients with schizophrenia were of mild to moderate
intensity, with the exception of one event of severe somnolence which resolved
after a few hours.

Some adverse events were reported, possibly linked to the use of the study
drug. These adverse events include dizziness, tiredness, headache, orthostatic
dizziness, non-sustained supra-ventricular tachycardia, sleepiness, poor sleep,
orthostatic hypotension, insomnia, muscle pain, defecation frequency decreased,
feeling of swollen tongue, light headedness, ALAT increase above 3 times of the
upper limit of the reference range (liver value), abdominal cramps, abdominal
pain, low blood pressure, increased creatine kinase (important enzyme for the
heart and other important organs), and vomiting.

The radioactive substance that is used for this study is broken down rapidly.

The blood collection may cause discomfort or bruising. Occasionally, fainting,
an infection at the blood sampling site, bleeding and blood clot formation can
occur.