Status:
COMPLETED
Competition With Striatal [11C]ORM-13070 Binding by Atipamezole and Endogenous Noradrenaline
Lead Sponsor:
University of Turku
Collaborating Sponsors:
Orion Corporation, Orion Pharma
Conditions:
Healthy
Eligibility:
MALE
20-40 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to validate \[11C\]ORM-13070 as an alpha2C-adrenoceptor imaging agent for human positron emission tomography (PET) studies of brain alpha2C-adrenoceptor occupancy.
Eligibility Criteria
Inclusion
- Written informed consent (IC) obtained.
- Good general health ascertained by detailed medical history, laboratory investigations and physical examination.
- Males between 20 and 40 years of age (inclusive).
- Body mass index (BMI) between 18-28 kg/m2 inclusive (BMI = weight/height2).
- Weight 60-100 kg (inclusive).
Exclusion
- Suspected poor compliance with the protocol or inability to communicate well with the study personnel.
- Veins unsuitable for repeated venipuncture.
- CYP2D6 slow metabolizer or ultrarapid metabolizer genotype.
- Evidence of clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, 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.
- Susceptibility to severe allergic reactions.
- Intake of any medication that could affect the outcome of the study, within 2 weeks prior to the tracer administration (2 months for enzyme inducing drugs like rifampicin or carbamazepine), or less than 5 times the half-life of the medication.
- 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 2 months prior to the screening visit.
- Abnormal 12-lead electrocardiogram (ECG) finding of clinical relevance after 10 minutes rest in supine position at the screening visit, for example:
- QTc (calculated using Bazett's formula) \> 450 msec,
- PR \< 120 msec or \> 210 msec,
- QRS \< 70 msec or \> 120 msec.
- Heart rate (HR) \< 40 beats/minute or \> 90 beats/minute after 10 minutes rest in supine position at the screening visit.
- At the screening visit, systolic blood pressure (BP) \< 90 mmHg or \> 140 mmHg after 10 minutes in supine position, diastolic BP \< 50 mmHg or \> 90 mmHg after 10 minutes in supine position.
- Any abnormal laboratory value, vital sign or physical examination result, which may in the opinion of the investigator interfere with the interpretation of the test results or cause a health risk to the subject if he takes part in the study.
- History of drug abuse or positive result in drug abuse test.
- Positive serology to human immunodeficiency virus antibodies (HIVAb), hepatitis B surface antigen (HBsAg) or hepatitis C virus antibodies (HCVAb).
- Anatomical abnormality in brain MRI which may in the opinion of the investigator interfere with the interpretation of the PET results.
- Any other condition that in the opinion of the investigator would interfere with the evaluation of the results or constitute a health risk to the subject.
- Participation in another clinical drug study within 3 months prior to this study.
- Participation in a prior PET study or other medical or occupational exposure to significant doses of ionizing radiation.
- Any contraindication to MRI of the brain.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01435213
Start Date
September 1 2011
End Date
January 1 2012
Last Update
February 18 2013
Active Locations (2)
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1
University of Turku, Clinical Research Services Turku CRST
Turku, Finland, 20520
2
University of Turku, Turku PET Centre
Turku, Finland, 20520