- 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.
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety and tolerability
Secondary outcome
Pharmacokinetics and pharmacodynamics
Background summary
The research medication is a new medication developed for the treatment of
Parkinson*s disease.
Study objective
- 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.
Study design
This is a randomised, double-blind, placebo-controlled single ascending dose
study.
Intervention
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.
Finally, a follow-up visit will take place.
Study burden and risks
Possible side effects may include headache, nausea, vomiting, increased heart
rate and lowered blood pressure which could lead to dizziness (in particular
with fast standing up).
The doses are chosen from research in lab animals. The risks with these doses
is likely to be minimal, but as with all clinical drug studies, unforeseeable
adverse reactions could occur. In order to keep the risks as low as possible,
subjects will be monitored carefully during the whole study.
Ottiliavej 9
2500 Copenhagen-Valby
DK
Ottiliavej 9
2500 Copenhagen-Valby
DK
Listed location countries
Age
Inclusion criteria
Healthy Male
Exclusion criteria
Clinical significant abnormalities at medical research
Design
Recruitment
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 | EUCTR2009-013125-42-NL |
CCMO | NL31521.056.10 |