Parallel-group, single and multiple dose interventional study investigating the tolerability and pharmacokinetic properties of Lu AF35700 in healthy young men

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

- to examine the safety and tolerability of the research medication
- to examine how the research medication is absorbed, broken down and excreted
by the body.

This is a parallel-group, single and multiple dose interventional study
investigating the tolerability and pharmacokinetic properties of the research
medication in healthy young 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 the study medication and
on several time points blood will be taken 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
sample will be taken.

Finally, a follow-up visit will take place.

Lu AF35700 has not been previously tested in humans. The compound of Lu AF35700
is expected to be similar to another drug within this class called zicronapine.
Clinical studies in healthy subject and in patients show that zicronapine have
been well tolerated in humans. Almost all reported adverse effects have been
mild-to-moderate in intensity. The most commonly reported side effects for
zicronapine are somnolence, sedation, insomnia, anxiety, agitation, weight
increase, headache and increased blood enzymes (AST, ALT, creatine
phosphokinase), orthostatic hypotension (decrease in blood pressure after
change in body positioning), heart trace (ECG) changes. Gastrointestinal side
effects such as stomach ache and constipation have also been reported.

Given the fact that Lu AF35700 is not a registered drug and has not been given
to humans before, the dose decided to be administered in this study has been
selected based on animal studies. The dose has been selected on a level, where
risks for side effects are considered to be minimal, but unforeseeable side
effects could occur. From animal studies, a risk of some minor extra beats from
the heart was identified, however there is included monitoring of the heart
during the study.

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