The purpose of this trial is to research how the new medication SCH 900062 after single and multiple dosing is absorbed, broken-down and excreted by the body when in the fasting state and after eating a high fat meal. This trial is necessary for theā¦
ID
Source
Brief title
Condition
- Cognitive and attention disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety and tolerability
Secondary outcome
Pharmacokinetics, bioavailability
Background summary
SCH 900062 is not registered as a medicine. SCH 900062 is a drug that is being
developed for the treatment of patients suffering from cognitive impairment.
Cognition is the name given to brain activities involving the processes of
learning, perception, remembering, thinking, interpreting, believing and
problem solving. In cases of cognitive impairment, these processes are
disrupted which can result in a reduced memory, attention span and flexibility
and can cause various conditions. These conditions include Alzheimer*s and
schizophrenia.
Study objective
The purpose of this trial is to research how the new medication SCH 900062
after single and multiple dosing is absorbed, broken-down and excreted by the
body when in the fasting state and after eating a high fat meal.
This trial is necessary for the further development of SCH 900062.
Study design
This trial is a triple-blind, randomized study with a placebo control group.
In part I 18 healthy male/female test subjects will participate in the trial
and will be split into two groups of 9 people. For both groups the trial
excists of 4 periods of 4 days wherein a single dose will be given.
In part II 36 healthy male/female test subjects will participate in the trial
and will be split into three groups of 12 people. For all groups the trial
excists of 1 periods of 16 days wherein a multiple dose will be given.
Study burden and risks
The test medication has not previously been tested in humans. Results from
animal testing have shown that with high doses, locomotion impairment can
occur, mostly observed as trembling of the limbs and an unsteady pace. It is
possible that this may also occur in this trial.
The dose levels are selected on the basis of research results in animals and
humans. The risks to health at these dose levels are limited but the subjects
may experience one of the above mentioned side-effects or other symptoms not
previously reported. The subject's health will be closely monitored during the
trial to minimize these risks.
PO Box 20
5340 BH Oss
Nederland
PO Box 20
5340 BH Oss
Nederland
Listed location countries
Age
Inclusion criteria
Males and females
Between 30-60 years of age
Exclusion criteria
Clinical significant abnormalities for medical examination
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 | EUCTR2009-017198-40-NL |
CCMO | NL30564.056.09 |