NCT01435213CompletedPhase 1
Competition With Striatal [11C]ORM-13070 Binding by Atipamezole and Endogenous Noradrenaline - a PET Study in Healthy Human Subjects
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- University of Turku
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- Receptor occupancy
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 20 Years to 40 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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 Criteria
- •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.
Arms & Interventions
Cold pressor test
Experimental
Intervention: Cold pressor test (Other)
Placebo
Experimental
Intervention: Placebo (Drug)
Insulin-induced hypoglycemia
Experimental
Intervention: Insulin (Drug)
Atipamezole
Experimental
Intervention: Atipamezole (Drug)
Ketamine
Experimental
Intervention: Ketamine (Drug)
Atomoxetine
Experimental
Intervention: Atomoxetine (Drug)
Outcomes
Primary Outcomes
Receptor occupancy
Time Frame: 30 minutes
PET tracer (interventional drug) uptake in the brain is measured for 30 minutes by PET after various pharmacological and physiological pre-treatments.
Secondary Outcomes
No secondary outcomes reported
Investigators
Juha Rinne
Professor
University of Turku
Study Sites (2)
Loading locations...
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