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

This study has been completed.
Information provided by:
Orion Corporation, Orion Pharma Identifier:
First received: August 13, 2008
Last updated: November 23, 2009
Last verified: November 2009
The purpose of the study is to evaluate the suitability of 11C-ORM-13070 as a positron emission tomography tracer.

Condition Intervention Phase
Drug: 11C-ORM-13070
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Suitability of 11C-ORM-13070 as a Positron Emission Tomography Tracer; an Open Study in Healthy Males

Further study details as provided by Orion Corporation, Orion Pharma:

Primary Outcome Measures:
  • Suitability of 11C-ORM-13070 as a PET tracer [ Time Frame: 1 day ]

Enrollment: 18
Study Start Date: August 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 11C-ORM-13070 Drug: 11C-ORM-13070
Single dose of i.v. solution


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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)

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00735774

Turku PET centre
Turku, Finland, 20520
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Principal Investigator: Juha Rinne, MD, PhD Turku PET Centre
  More Information

Responsible Party: Orion Corporation, Orion Pharma (Aila Holopainen, Clinical Study Director), Clinical study management Identifier: NCT00735774     History of Changes
Other Study ID Numbers: 3099001
Study First Received: August 13, 2008
Last Updated: November 23, 2009

Keywords provided by Orion Corporation, Orion Pharma:
Healthy volunteer study processed this record on May 25, 2017