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

NCT00735774 | Completed Phase 1

• 1 other identifier: 3099001
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Healthy volunteer study

Outcome Measures

Primary Outcomes (1)

• Suitability of 11C-ORM-13070 as a PET tracer

  1 day

Study Arms (1)

11C-ORM-13070

EXPERIMENTAL

Drug: 11C-ORM-13070

Interventions

11C-ORM-13070 DRUG

Single dose of i.v. solution

11C-ORM-13070

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Orion Corporation, Orion Pharma: lead

Study Sites (1)

Turku PET centre

Turku, 20520, Finland

Location

MeSH Terms

Interventions

1-(1-(2,3-dihydrobenzo(1,4)dioxin-2-yl)methyl)-4-(3-methoxymethylpyridin-2-yl)piperazine

Study Officials

• Juha Rinne, MD, PhD

  Turku PET Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 13, 2008
• First Posted: August 15, 2008
• Study Start: August 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: November 25, 2009

Record last verified: 2009-11

Locations

FI (1)