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Suitability of 11C-ORM-13070 as a PET Tracer

Phase 1
Completed
Conditions
Healthy
Interventions
Registration Number
NCT00735774
Lead Sponsor
Orion Corporation, Orion Pharma
Brief Summary

The purpose of the study is to evaluate the suitability of 11C-ORM-13070 as a positron emission tomography tracer.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
18
Inclusion Criteria
  • Good general health ascertained by detailed medical history and physical examination
  • Males between 18 and 45 years
  • Body mass index (BMI) between 18-30 kg/m2
  • Weight 55-95 kg (inclusive)
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Exclusion Criteria
  • 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 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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
11C-ORM-1307011C-ORM-13070-
Primary Outcome Measures
NameTimeMethod
Suitability of 11C-ORM-13070 as a PET tracer1 day
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Turku PET centre

🇫🇮

Turku, Finland

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