A PET Study With ORM-12741

This study has been completed.
Sponsor:
Information provided by:
Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier:
NCT00829907
First received: December 11, 2008
Last updated: November 23, 2009
Last verified: November 2009
  Purpose

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 Intervention Phase
Healthy
Drug: ORM-12741
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: 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

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

Primary Outcome Measures:
  • Receptor occupancy [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetic variables including peak concentration in plasma, time to peak concentration, area under the plasma concentration-time curve [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 26
Study Start Date: January 2009
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Orm-12741
Drug: ORM-12741
Single dose as a capsule, oral administration

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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; 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00829907

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

No publications provided

Responsible Party: Orion Corporation, Orion Pharma (Aila Holopainen, Clinical Study Director), Clinical study management
ClinicalTrials.gov Identifier: NCT00829907     History of Changes
Other Study ID Numbers: 3098005
Study First Received: December 11, 2008
Last Updated: November 23, 2009
Health Authority: Finland: Finnish Medicines Agency

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

ClinicalTrials.gov processed this record on August 28, 2014