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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: 11C-ORM-13070

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• Finland
  • Turku, Finland, 20520
    • Turku PET Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 11C-ORM-13070	Drug: 11C-ORM-13070; Single dose of i.v. solution

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Orion Corporation, Orion Pharma
• Investigators: Principal Investigator: Juha Rinne, MD, PhD, Turku PET Centre

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: August 13, 2008
• First Submitted That Met QC Criteria: August 13, 2008
• First Posted (Estimate): August 15, 2008

Study Record Updates

• Last Update Posted (Estimate): November 25, 2009
• Last Update Submitted That Met QC Criteria: November 23, 2009
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Keywords: Healthy volunteer study
• Other Study ID Numbers: 3099001