Healthy
Conditions
Keywords
Healthy volunteer study
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.
Interventions
DRUGORM-12741
Single dose as a capsule, oral administration
Sponsors
Orion Corporation, Orion Pharma
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Receptor occupancy | 1 day |
Secondary
| Measure | 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 |
Countries
Finland
Outcome results
None listed