- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01435213
Competition With Striatal [11C]ORM-13070 Binding by Atipamezole and Endogenous Noradrenaline (AIMI)
February 15, 2013 updated by: Juha Rinne, University of Turku
Competition With Striatal [11C]ORM-13070 Binding by Atipamezole and Endogenous Noradrenaline - a PET Study in Healthy Human Subjects
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Turku, Finland, 20520
- University of Turku, Clinical Research Services Turku CRST
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Turku, Finland, 20520
- University of Turku, Turku PET Centre
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Placebo
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A single dose of placebo (capsules) administered orally
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Experimental: Ketamine
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A single dose of ketamine (approximately 60 mg) administered as an intravenous infusion
Other Names:
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Experimental: Atomoxetine
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A single dose of 1.2 mg/kg of atomoxetine administered orally
Other Names:
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Experimental: Atipamezole
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Administration of a single dose of 5-150 micrograms of atipamezole as an intravenous infusion
Other Names:
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Experimental: Insulin-induced hypoglycemia
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Insulin administered as an intravenous infusion to induce hypoglycemia
Other Names:
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Experimental: Cold pressor test
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30-45 min cold pressor test of the foot
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Receptor occupancy
Time Frame: 30 minutes
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PET tracer (interventional drug) uptake in the brain is measured for 30 minutes by PET after various pharmacological and physiological pre-treatments.
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30 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Juha Rinne, MD, PhD, University of Turku
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (Actual)
January 1, 2012
Study Completion (Actual)
January 1, 2012
Study Registration Dates
First Submitted
September 14, 2011
First Submitted That Met QC Criteria
September 15, 2011
First Posted (Estimate)
September 16, 2011
Study Record Updates
Last Update Posted (Estimate)
February 18, 2013
Last Update Submitted That Met QC Criteria
February 15, 2013
Last Verified
February 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Dissociative
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Adrenergic Uptake Inhibitors
- Adrenergic alpha-Antagonists
- Adrenergic alpha-2 Receptor Antagonists
- Insulin
- Ketamine
- Insulin, Globin Zinc
- Atomoxetine Hydrochloride
- Atipamezole
Other Study ID Numbers
- 3099002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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