A PET Study With ORM-12741

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: ORM-12741

• Registration Number: NCT00829907
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-12-11
• Study Start: 2009-01
• Study First Submitted QC: 2009-01-26
• Study First Posted: 2009-01-27
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2009-11
• Last Update Submitted: 2009-11-23
• Last Update Posted: 2009-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	ORM-12741	Orm-12741

Primary Outcome Measures

Name	Time	Method
Receptor occupancy	1 day

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Turku PET centre; 🇫🇮 Turku, Finland