HealthyPhase 1AIMINCT01435213
Competition With Striatal [11C]ORM-13070 Binding by Atipamezole and Endogenous Noradrenaline
A Phase 1 study testing Atipamezole, Atomoxetine and Ketamine in people with Healthy, run by University of Turku at 2 sites in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Atipamezole, Atomoxetine and Ketamine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 2 sitesFinland
- Study dates
- Sep 2011to Jan 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 26Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
University of Turku, Clinical Research Services Turku CRST
Turku, 20520
University of Turku, Turku PET Centre
Turku, 20520
About this study
Official title: 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.
- Conditions
- Healthy
- Keywords
- alpha2-adrenoceptor, receptor occupancy, positron emission tomography, [11C]ORM-13070, striatum, brain, noradrenaline, norepinephrine, endogenous, binding, Validation studies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtipamezoleDrug
Also called ANTISEDAN VET
Administration of a single dose of 5-150 micrograms of atipamezole as an intravenous infusion
AtomoxetineDrug
Also called Strattera
A single dose of 1.2 mg/kg of atomoxetine administered orally
KetamineDrug
Also called Ketalar
A single dose of ketamine (approximately 60 mg) administered as an intravenous infusion
Cold pressor testOther
30-45 min cold pressor test of the foot
InsulinDrug
Also called Insulin Actrapid
Insulin administered as an intravenous infusion to induce hypoglycemia
PlaceboDrug
A single dose of placebo (capsules) administered orally
| Study group | Role | What they receive |
|---|---|---|
| Atipamezole | Experimental | Not described Receives: Drug: Atipamezole |
| Atomoxetine | Experimental | Not described Receives: Drug: Atomoxetine |
| Ketamine | Experimental | Not described Receives: Drug: Ketamine |
| Insulin-induced hypoglycemia | Experimental | Not described Receives: Drug: Insulin |
| Cold pressor test | Experimental | Not described Receives: Other: Cold pressor test |
| Placebo | Experimental | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Receptor occupancy
PET tracer (interventional drug) uptake in the brain is measured for 30 minutes by PET after various pharmacological and physiological pre-treatments.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- Collaborators
- Orion Corporation, Orion Pharma
- Responsible party
- Principal investigator, Juha Rinne, University of Turku
- Investigators
- Juha Rinne, MD, PhD, Principal investigator, University of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01435213
- Sponsor's protocol ID
- 3099002
- Acronym
- AIMI
- Status last verified
- Feb 2013
- First submitted
- 14 Sep 2011
- Last updated
- 18 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Competition With Striatal [11C]ORM-13070 Binding by Atipamezole and Endogenous Noradrenaline - a PET Study in Healthy Human Subjects
- ClinicalTrials.gov ID
- NCT01435213
- Acronym / sponsor ID
- AIMI / 3099002
- Conditions
- Healthy
- Keywords
- alpha2-adrenoceptor, receptor occupancy, positron emission tomography, [11C]ORM-13070, striatum, brain, noradrenaline, norepinephrine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Collaborators
- Orion Corporation, Orion Pharma
- Study start
- Sep 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 16 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Atipamezole | Experimental | Drug: Atipamezole |
| Atomoxetine | Experimental | Drug: Atomoxetine |
| Ketamine | Experimental | Drug: Ketamine |
| Insulin-induced hypoglycemia | Experimental | Drug: Insulin |
| Cold pressor test | Experimental | Other: Cold pressor test |
| Placebo | Experimental | Drug: Placebo |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtipamezoleAlso: ANTISEDAN VETAdministration of a single dose of 5-150 micrograms of atipamezole as an intravenous infusion | Drug | Atipamezole |
| AtomoxetineAlso: StratteraA single dose of 1.2 mg/kg of atomoxetine administered orally | Drug | Atomoxetine |
| KetamineAlso: KetalarA single dose of ketamine (approximately 60 mg) administered as an intravenous infusion | Drug | Ketamine |
| Cold pressor test30-45 min cold pressor test of the foot | Other | Cold pressor test |
| InsulinAlso: Insulin ActrapidInsulin administered as an intravenous infusion to induce hypoglycemia | Drug | Insulin-induced hypoglycemia |
| PlaceboA single dose of placebo (capsules) administered orally | Drug | Placebo |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2013.
- Clinical Research Services Turku CRSTLink provided by the sponsor.
- Turku PET CentreLink provided by the sponsor.
Related trials for Healthy
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Active, not recruitingPhase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body of Healthy Adults
Healthy
Not yet recruitingObservational study
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Blood Donors, Apheresis
Recruiting
Metabolic Impact of VLCPUFA-Rich Fish Oil: A Clinical Study on Omega-3 Index Enhancement in Healthy Individuals
Fatty Acids, Omega-3, Fish Oils
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juha Rinne, MD, PhD principal investigator
University of Turku
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Atipamezole, Atomoxetine and Ketamine in people with Healthy, run by University of Turku at 2 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Receptor occupancy (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2013.