Suitability of 11C-ORM-13070 as a PET Tracer

Suitability of 11C-ORM-13070 as a Positron Emission Tomography Tracer; an Open Study in Healthy Males

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00735774

Enrollment

Registered

2008-08-15

Start date

2008-08-31

Completion date

2009-05-31

Last updated

2009-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Healthy volunteer study

Brief summary

The purpose of the study is to evaluate the suitability of 11C-ORM-13070 as a positron emission tomography tracer.

Interventions

DRUG11C-ORM-13070

Single dose of i.v. solution

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

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

Design outcomes

Primary

Measure	Time frame
Suitability of 11C-ORM-13070 as a PET tracer	1 day

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026