The objective of the study is to observe the effect of olanzapineat a dose of 10 mg daily for 14 days when given with/without topiramaat at a dose of 25 and 50 mg twice daily on bodyweight in healthy male subjects. In addition the effect of…
ID
Source
Brief title
Condition
- Other condition
- Thyroid gland disorders
Synonym
Health condition
lichaamsgewicht
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To compare the effects of 14 days of daily dosing of 10 mg olanzapine with or
without topiramate at a dose of 25 and 50 mg twice daily on body weight in
healthy male subjects
Secondary outcome
To assess if olanzapine at a dose of 10 mg daily for 14 days with or without
topiramate at a dose of 25 and 50 mg twice daily has an effect on thyroid
function, glucose and lipid metabolism in healthy male subjects
Background summary
Effect of olanzapine with or without topiramaat on the metabolism
Study objective
The objective of the study is to observe the effect of olanzapineat a dose of
10 mg daily for 14 days when given with/without topiramaat at a dose of 25
and 50 mg twice daily on bodyweight in healthy male subjects. In addition the
effect of olanzapine on the thyroid gland and the metabolism of glucose and fat
in the body will be observed.
Study design
Procedures and assessments:
Screening and follow-up:
Clinical laboratory, bloodpressure and vital signs, physical examination,
12-lead ECG, drug screen
Only by screening:
medical history, height, weight, HBsAG, anti HCV and anti-HIV.
subjects will be in the clinic for 2 periods. For Period 1, the subjects will
arrive at the clinic 2 days preceding the day of the first drug administration
(Day 1 is the day of (the first) drug administration) and they will leave on
Day 16 (48 hours after the last drug administration). For Period 2, the
subjects will arrive at the clinic on Day 27 and they will leave the clinic on
Day 28.
Intervention
Active substance :olanzapine topiramate
Activity : anti-psychotic anti-epileptic
Indication : schizophrenia migraine and epilepsy
Strength : 10 mg 25 mg
Dosage form: tablet encapsulated tablet
Study burden and risks
Procedures: pain, light bleeding, heamatoma and possibly an infection.
Stationsweg 163
9471 GP Zuidlaren
Nederland
Stationsweg 163
9471 GP Zuidlaren
Nederland
Listed location countries
Age
Inclusion criteria
Healthy male subjects
24-45 yrs, inclusive
22-30 kg/m2, inclusive
Exclusion criteria
Suffering from: hepatitis B, cancer or HIV/Aids. In case of participation in another drug study within 60 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters blood in the 10 months preceding the start of the 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 | EUCTR2010-019664-37-NL |
| CCMO | NL32196.056.10 |