MedDataX Logo

A PET Study With ORM-12741

NCT ID: NCT00829907

Last Updated: 2009-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of the study is to evaluate the effect of ORM-12741 on receptor occupancy by positron emission tomography with different doses and plasma concentrations. The pharmacokinetic profile and safety will also be evaluated.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Healthy volunteer study

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Orm-12741

Group Type EXPERIMENTAL

ORM-12741

Intervention Type DRUG

Single dose as a capsule, oral administration

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ORM-12741

Single dose as a capsule, oral administration

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Good general health ascertained by detailed medical history and physical examination
* Males between 18 and 45 years
* Body mass index (BMI; weight/height2) between 18-30 kg/m2
* Weight 55-95 kg

Exclusion Criteria

* Evidence of clinically significant cardiovascular, renal, hepatic, haematological, gastro-intestinal, 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
* 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 3 months prior to the screening visit
* Abnormal 12-lead electrocardiogram (ECG) finding of clinical relevance
* Any abnormal value of laboratory, vital signs, or physical examination, which may in the opinion of the investigator interfere with the interpretation of the test results or cause a health risk for the subject if he takes part into the study
* Anatomical abnormality in brain MRI which may in the opinion of the investigator interfere with the interpretation of the PET results
* Participation in another clinical drug study within 3 months prior to the start of this study or earlier participation in a clinical study with ORM-12741
* Participation in a prior PET study
* Any contraindication to MRI of the brain
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Orion Corporation, Orion Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Clinical study management

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Juha Rinne, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Turku PET Centre

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Turku PET centre

Turku, , Finland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Finland

References

Explore related publications, articles, or registry entries linked to this study.

Shahid M, Rinne JO, Scheinin M, Virta J, Marjamaki P, Solin O, Arponen E, Sallinen J, Kuokkanen K, Rouru J. Application of the PET ligand [11C]ORM-13070 to examine receptor occupancy by the alpha2C-adrenoceptor antagonist ORM-12741: translational validation of target engagement in rat and human brain. EJNMMI Res. 2020 Dec 9;10(1):152. doi: 10.1186/s13550-020-00741-y.

Reference Type DERIVED
PMID: 33296042 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

3098005

Identifier Type: -

Identifier Source: org_study_id