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CompletedNCT00829907Updated Nov 25, 2009

A PET Study With ORM-12741

A Phase 1 interventional study of ORM-12741 in Healthy, sponsored by Orion Corporation, Orion Pharma. Completed at 1 site in Finland. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-11-25.

Sponsored by Orion Corporation, Orion Pharma · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
26
Allocation
Non-randomized
Ages
18 Years to 45 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Healthy

Keywords

  • Healthy volunteer study
03

In context

Lead sponsor

Orion Corporation, Orion Pharma is the lead sponsor of 100 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 1
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
26 participants (actual)

Study arms

  • Experimental
    1

    Orm-12741

    Drug: ORM-12741

Interventions

  • DrugORM-12741

    Single dose as a capsule, oral administration

06

What researchers measure

Primary outcomes

  1. Receptor occupancy

    Time frame: 1 day

Secondary outcomes

  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

07

Study locations

1 site
  • Turku PET centre
    Turku, 20520, Finland
08

References and documents

Publications

  • Shahid M, Rinne JO, Scheinin M, Virta J, Marjamaki P, Solin O, Arponen E, Sallinen J, Kuokkanen K, Rouru J. Application of the PET ligand [11C]ORM-13070 to examine receptor occupancy by the alpha2C-adrenoceptor antagonist ORM-12741: translational validation of target engagement in rat and human brain. EJNMMI Res. 2020 Dec 9;10(1):152. doi: 10.1186/s13550-020-00741-y. PubMed 33296042 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 25, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00829907
Lead sponsor
Orion Corporation, Orion Pharma
First posted
Jan 27, 2009
Start date
Jan 2009
Primary completion
Jun 2009
Completion
Jun 2009
Last update
Nov 25, 2009

Study contacts

Juha Rinne, MD, PhD
principal investigator · Turku PET Centre

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2009. You cannot join it, but the record below documents what was studied.

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