- 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
The study medication has not been previously tested in humans. However,
pharmacological compounds with similar mode of action have been tested in human
clinical trials, but are not yet registered by authorities for use in patients.
The results, seen in literature, obtained from these tested compounds indicated
that such compounds are generally well tolerated and some side effects have
been reported. These most common adverse effects in patients with Parkinson*s
disease appear to be nausea, aggravation of dyskinesia, dizziness and insomnia.
The doses decided to be administered in this study have been decided based on
data from preclinical studies in animals. The risks with these doses are
considered to be minimal, but as with drugs, unforeseeable side effects could
occur. In order to minimize the risks, the health 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 and female
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 | EUCTR2011-000204-17-NL |
CCMO | NL38574.056.11 |