Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
18 participants
INTERVENTIONAL
2008-08-31
2009-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
NONE
Study Groups
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11C-ORM-13070
11C-ORM-13070
Single dose of i.v. solution
Interventions
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11C-ORM-13070
Single dose of i.v. solution
Eligibility Criteria
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Inclusion Criteria
* Males between 18 and 45 years
* Body mass index (BMI) between 18-30 kg/m2
* Weight 55-95 kg (inclusive)
Exclusion Criteria
* 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 in the study centre
* Inability to refrain from consuming caffeine-containing beverages during the stay in the study centre e.g. propensity in getting 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 MRI which may in the opinion of the investigator interfere with the interpretation of PET results
* Participation in a drug study within 3 months prior to the entry into this study
* Participation in a prior PET study
18 Years
45 Years
MALE
Yes
Sponsors
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Orion Corporation, Orion Pharma
INDUSTRY
Responsible Party
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Clinical study management
Principal Investigators
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Juha Rinne, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Turku PET Centre
Locations
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Turku PET centre
Turku, , Finland
Countries
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Other Identifiers
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3099001
Identifier Type: -
Identifier Source: org_study_id