Status:
COMPLETED
A PET Study With ORM-12741
Lead Sponsor:
Orion Corporation, Orion Pharma
Conditions:
Healthy
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
The purpose of the study is to evaluate the effect of ORM-12741 on receptor occupancy by positron emission tomography with different doses and plasma concentrations. The pharmacokinetic profile and sa...
Eligibility Criteria
Inclusion
- Good general health ascertained by detailed medical history and physical examination
- Males between 18 and 45 years
- Body mass index (BMI; weight/height2) between 18-30 kg/m2
- Weight 55-95 kg
Exclusion
- Evidence of clinically significant cardiovascular, renal, hepatic, haematological, gastro-intestinal, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric disease as judged by the investigator
- Any condition requiring regular concomitant medication including herbal products or likely to need any concomitant medication during the study
- Regular consumption of more than 21 units of alcohol per week (1 unit = 4 cl spirits, about 13 g of alcohol).
- Current use of nicotine-containing products more than 5 cigarettes or equivalent/day
- Inability to refrain from using nicotine-containing products during the stay at the study centre
- Inability to refrain from consuming caffeine-containing beverages during the stay at the study centre e.g. propensity for headache when refraining from caffeine-containing beverages
- Blood donation or loss of significant amount of blood within 3 months prior to the screening visit
- Abnormal 12-lead electrocardiogram (ECG) finding of clinical relevance
- Any abnormal value of laboratory, vital signs, or physical examination, which may in the opinion of the investigator interfere with the interpretation of the test results or cause a health risk for the subject if he takes part into the study
- Anatomical abnormality in brain MRI which may in the opinion of the investigator interfere with the interpretation of the PET results
- Participation in another clinical drug study within 3 months prior to the start of this study or earlier participation in a clinical study with ORM-12741
- Participation in a prior PET study
- Any contraindication to MRI of the brain
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00829907
Start Date
January 1 2009
End Date
June 1 2009
Last Update
November 25 2009
Active Locations (1)
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1
Turku PET centre
Turku, Finland, 20520