An open-label, one-sequence crossover interaction study investigating the effect of multiple doses of Lu AE58054 on cytochrome P450 3A4 and 2D6 activity measured by midazolam and dextromethorphan pharmacokinetics in healthy young men

The research medication is a new medication developed for the treatment of
cognitive impairment associated with Schizophrenia and Alzheimer's disease

To study how the registered medicine Midazolam is absorbed, broken-down and
excreted by the body after or without administration of multiple doses of the
test compound.

To study how the registered medicine Dextromethorphan is absorbed, broken-down
and excreted by the body after or without administration of multiple doses of
the test compound.

To investigate the safety and tolerability of the test compound after multiple
dosing alone or in combination with single dosing of the registered medicines
Midazolam and Dextromethorphan.

An open-label, one-sequence crossover interaction study investigating the
effect of multiple doses of research medication measured by midazolam and
dextromethorphan pharmacokinetics

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
labortaory tests. An alcohol breath test and drug screen will also be performed.

During the stay in the clinic, the subject will receive the study medication
(including Midazolam and Dextromethorphan) and on several time-points blood
will be taken. The subjects will be asked for possible side effects on a
regular basis. Furthermore ECG's and vitals signs assessments will be performed
and checked regularly

Finally a follow-up visit will take place

Possible side effects of the research medication may include dizziness,
headache and a numb tongue, gastrointestinal disorders (dry mouth and vomiting)
and nervous system disorders (headache, dizziness, sedation, anxiety)

Dextromethorphan and Midazolam are drugs which are prescribed and used
clinically for long time.

Possible side effects of Dextromethorphan may include stomach upset, nausea,
drowsiness, and dizziness.

Possible side effects of Midazolam may include drowsiness, cognitive
impairment, sedation, confusion, headache, dizziness and double vision.