NCT00735774CompletedPhase 1
Suitability of 11C-ORM-13070 as a Positron Emission Tomography Tracer; an Open Study in Healthy Males
Orion Corporation, Orion Pharma1 site in 1 country18 target enrollmentStarted: August 2008Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Suitability of 11C-ORM-13070 as a PET tracer
Study Overview
Brief Summary
The purpose of the study is to evaluate the suitability of 11C-ORM-13070 as a positron emission tomography tracer.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Good general health ascertained by detailed medical history and physical examination
- •Males between 18 and 45 years
- •Body mass index (BMI) between 18-30 kg/m2
- •Weight 55-95 kg (inclusive)
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 in the study centre
- •Inability to refrain from consuming caffeine-containing beverages during the stay in the study centre e.g. propensity in getting 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 MRI which may in the opinion of the investigator interfere with the interpretation of PET results
- •Participation in a drug study within 3 months prior to the entry into this study
- •Participation in a prior PET study
Arms & Interventions
11C-ORM-13070
Experimental
Intervention: 11C-ORM-13070 (Drug)
Outcomes
Primary Outcomes
Suitability of 11C-ORM-13070 as a PET tracer
Time Frame: 1 day
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Not Applicable
Diagnostic value of 11C-metomidate Positron Emission Tomography/Computerized Tomography (PET/CT) for the evaluation of primary aldosteronism: a pilot studyprimary aldosteronism - Conn's syndrome - overactive adrenal gland with excessive secretion of aldosterone10001353NL-OMON35185niversitair Medisch Centrum Groningen10
Active, not recruiting
Phase 1
Feasibility of [11C]Acetate-PET in LAM and TSCLymphangioleiomyomatosisTuberous Sclerosis ComplexNCT05467397Brigham and Women's Hospital7
Completed
Not Applicable
The study on the usefulness of positron emission tomography wtih [11C]PBB3Alzheimer's disease Psychotic disorders Mood disorders Traumatic brain injury EpilepsyJPRN-UMIN000014785ippon Medical School120
Completed
Phase 1
Evaluation of Histamine H3 Receptor Radioligand [11C]AZ12807110 and Histamine H3 Receptor Occupancy of AZD5213 After Oral AdministrationBrain Distribution of [11C]AZ12807110 and AZD5213NCT01194986AstraZeneca13
Terminated
Early Phase 1
Safety and Efficacy of Positron Emission Tomography Imaging With MNI-513Alzheimer DiseaseNCT01000870Institute for Neurodegenerative Disorders6