The purpose of the study is to find out if there is a possible influence of Ketoconazole on the effect of RO4602522 (this is called pharmacodynamics). it will be investigated whether and if so to what extent Ketoconazole influences how fast…
ID
Source
Brief title
Condition
- Neurological disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pharmacokinetics:
Bloodsamples for the analysis of RO4602522 and metabolitesy will be collected
during the clinic period.
Urine for the analysis of RO4602522 will be collected during the clinic period
at he clinic until 48 hours after dosing.
Secondary outcome
NA
Background summary
RO4602522 is a new investigational compound that may eventually be used for the
treatment of Alzheimer*s disease.
RO4602522 is an inhibitor of MAO-B. MAO-B has been chosen as a target for drug
development in Alzheimer*s disease
because there is evidence to suggest that it is involved in the etiology of the
disease. In patients with Alzeimer*s disease,
brain MAO-B activity is increased compared with age-matched controls.
RO4602522 is not registered as a drug but has been given to humans before.
Study objective
The purpose of the study is to find out if there is a possible influence of
Ketoconazole on the effect of RO4602522 (this is called pharmacodynamics). it
will be investigated whether and if so to what extent Ketoconazole influences
how fast RO4602522 is absorbed and eliminated from the body (this is called
pharmacokinetics).
In addition it will be investigated wheter RO4602522 administrated with
Ketoconazole is safe and well tolerated.
Study design
This is an non-randomized parallel, open-label study, with 34 healthy male
volunteers. The volunteers will receive RO4602522 and/or ketoconazole as a
tablet for oral administration.
Intervention
Group 1 will receive a single dose of 15 mg study medication RO4602522 in the
form of an oral tablet on Day 1.
Group 2 will receive a twice daily dose of 200 mg Ketoconazole in the form of
an oral tablet from Day 1 until Day 17. Also on Day 4 this group will receive a
single dose of 15 mg study medication RO4602522 in the form of an oral tablet
in combination with Ketoconazole.
Study burden and risks
Procedures: pain, light bleeding, heamatoma, possible an infection after blood
draw i.e. indwelling canula.
Grenzacherstrasse 124,
4070 Basel
CH
Grenzacherstrasse 124,
4070 Basel
CH
Listed location countries
Age
Inclusion criteria
healthy male subjects
18-45 yrs, inclusive
BMI: 18.0-30.0 kg/m2, inclusive
non-smoking
Exclusion criteria
Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 90 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2012-001195-11-NL |
| CCMO | NL40681.056.12 |