A PET Study With ORM-12741

Study Overview
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Brief Summary
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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.

Official Title
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Effect of ORM-12741 on Receptor Occupancy Studied by Positron Emission Tomography; an Open, Single Dose, Dose Ranging Study in Healthy Males

Conditions
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Healthy

Intervention / Treatment
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* Drug: ORM-12741


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Orm-12741 | Drug: ORM-12741<br>* Single dose as a capsule, oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Receptor occupancy |  | 1 day | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy volunteer study