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

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

      • Turku, Finland, 20520
        • University of Turku, Clinical Research Services Turku CRST
      • Turku, Finland, 20520
        • University of Turku, Turku PET Centre

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
A single dose of placebo (capsules) administered orally
Experimental: Ketamine
A single dose of ketamine (approximately 60 mg) administered as an intravenous infusion
Other Names:
  • Ketalar
Experimental: Atomoxetine
A single dose of 1.2 mg/kg of atomoxetine administered orally
Other Names:
  • Strattera
Experimental: Atipamezole
Administration of a single dose of 5-150 micrograms of atipamezole as an intravenous infusion
Other Names:
  • ANTISEDAN VET
Experimental: Insulin-induced hypoglycemia
Insulin administered as an intravenous infusion to induce hypoglycemia
Other Names:
  • Insulin Actrapid
Experimental: Cold pressor test
30-45 min cold pressor test of the foot

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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.

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

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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