Status:
COMPLETED
Excretion Balance and Metabolism After a Single Oral Dose of 14C-Labelled ORM-12741
Lead Sponsor:
Orion Corporation, Orion Pharma
Conditions:
Healthy Male Volunteers
Eligibility:
MALE
18-60 years
Phase:
PHASE1
Brief Summary
The study is conducted to examine absorption of C14-ORM-12741 from intestine to bloodstream, distribution to bloodstream, metabolism in the liver and excretion of the parent drug and metabolites to fa...
Detailed Description
Six healthy males will receive 3 mg of ORM-12741 as a single oral solution(0.1mg/mL). The oral dose contains 0.73 mg of 14C-ORM-12741 (2.5 MBq), 1 mg of 13C-ORM-12741 and 1.27 mg of ORM-12741. Subjec...
Eligibility Criteria
Inclusion
- Gender male
- Age 18-60 years, inclusive
- Weight 55-100 kg, inclusive
- Body mass index (BMI) 18.0 - 30.0 kg/m2 (inclusive)
- Ability and willingness to abstain from alcohol, tobacco products, methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, "power drinks"), and grape fruit (juice) from 48 hours prior to entry in the clinical research centre until discharge
- Medical history without major pathology
- All values for haematology and for clinical chemistry tests of blood and urine within normal range or showing no clinically relevant deviations as judged by the Medical Investigator
- Willingness to use adequate contraception from the time of dosing until three months after the end-of-study visit
- Willingness to sign the written Informed Consent Form (ICF)
Exclusion
- Evidence of clinically relevant pathology
- Mental handicap
- History of relevant drug and/or food allergies
- At screening visit, abnormal 12-lead ECG of clinical relevance
- Regular/routine treatment with non-topical medication within 30 days prior to drug administration
- Irregular defecation pattern (less than once per two days)
- Exposure to radiation for diagnostic reasons (except dental X-days and plain X-rays of thorax and body skeleton (excluding spinal column)) during work or during participation in a medical trial in the previous year
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2009
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00817544
Start Date
January 1 2009
End Date
March 1 2009
Last Update
March 16 2009
Active Locations (1)
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1
PRA International
AE Zuitlaren, Netherlands, 9470