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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00735774
First Posted: August 15, 2008
Last Update Posted: November 25, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Orion Corporation, Orion Pharma
  Purpose
The purpose of the study is to evaluate the suitability of 11C-ORM-13070 as a positron emission tomography tracer.

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00735774


Locations
Finland
Turku PET centre
Turku, Finland, 20520
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Investigators
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
ClinicalTrials.gov Identifier: NCT00735774     History of Changes
Other Study ID Numbers: 3099001
First Submitted: August 13, 2008
First Posted: August 15, 2008
Last Update Posted: November 25, 2009
Last Verified: November 2009

Keywords provided by Orion Corporation, Orion Pharma:
Healthy volunteer study