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Competition With Striatal [11C]ORM-13070 Binding by Atipamezole and Endogenous Noradrenaline

Information source: University of Turku
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Atipamezole (Drug); Atomoxetine (Drug); Ketamine (Drug); Cold pressor test (Other); Insulin (Drug); Placebo (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: University of Turku

Official(s) and/or principal investigator(s):
Juha Rinne, MD, PhD, Principal Investigator, Affiliation: University of Turku


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.

Clinical Details

Official title: Competition With Striatal [11C]ORM-13070 Binding by Atipamezole and Endogenous Noradrenaline - a PET Study in Healthy Human Subjects

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Primary outcome: Receptor occupancy


Minimum age: 20 Years. Maximum age: 40 Years. Gender(s): Male.


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.

Locations and Contacts

University of Turku, Clinical Research Services Turku CRST, Turku 20520, Finland

University of Turku, Turku PET Centre, Turku 20520, Finland

Additional Information

Clinical Research Services Turku CRST

Turku PET Centre

Starting date: September 2011
Last updated: February 15, 2013

Page last updated: August 23, 2015

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