A PET Study With ORM-12741

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. Identifier: NCT00829907
Recruitment Status : Completed
First Posted : January 27, 2009
Last Update Posted : November 25, 2009
Information provided by:
Orion Corporation, Orion Pharma

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 safety will also be evaluated.

Condition or disease Intervention/treatment Phase
Healthy Drug: ORM-12741 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Effect of ORM-12741 on Receptor Occupancy Studied by Positron Emission Tomography; an Open, Single Dose, Dose Ranging Study in Healthy Males
Study Start Date : January 2009
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Arm Intervention/treatment
Experimental: 1
Drug: ORM-12741
Single dose as a capsule, oral administration

Primary Outcome Measures :
  1. Receptor occupancy [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. Pharmacokinetic variables including peak concentration in plasma, time to peak concentration, area under the plasma concentration-time curve [ Time Frame: 1 day ]
  2. Safety variables including blood pressure, heart rate, electrocardiogram, physical examination, laboratory safety variables (haematology, chemistry, serology, urinanalysis) and adverse events. [ Time Frame: During the study ]

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

Inclusion Criteria:

  • 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 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 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

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 identifier (NCT number): NCT00829907

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

Responsible Party: Orion Corporation, Orion Pharma (Aila Holopainen, Clinical Study Director), Clinical study management Identifier: NCT00829907     History of Changes
Other Study ID Numbers: 3098005
First Posted: January 27, 2009    Key Record Dates
Last Update Posted: November 25, 2009
Last Verified: November 2009

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