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Sponsored by: |
Orion Corporation, Orion Pharma |
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Information provided by: | Orion Corporation, Orion Pharma |
ClinicalTrials.gov Identifier: | NCT00817544 |
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 faeces, urine and expired air
Condition | Intervention | Phase |
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Healthy Male Volunteers |
Drug: ORM-12741 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study |
Official Title: | Excretion Balance and Metabolism After a Single Oral Dose of 14C-Labelled ORM-12741; an Open, Non-Randomised, Single Centre Study in Healthy Male Subjects |
Estimated Enrollment: | 6 |
Study Start Date: | January 2009 |
Study Completion Date: | March 2009 |
Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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ORM-12741: Experimental
ORM-12741
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Drug: ORM-12741
3 mg of ORM-12741 as a single dose. Contains 0.73 mg (2.5 MBq) 14C labelled ORM-12741
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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.
Subjects will be confined to the study site from Day -1 (the afternoon prior to the day of dosing) up to at least 168 hours following drug administration (Day 8). Subjects will be discharged on Day 8 if radioactivity in urine and faeces meet pre-defined criteria (urinary excretion <0.5% and faecal excretion <0.5% of the dose per 24 hours based on 14C radioactivity quick counts, which will be measured from Day 7 onwards). If on Day 8 these pre defined criteria are not met, subjects will remain hospitalised for a maximum of seven more days (Day 15) until the criteria are met (daily check on quick counts). If on Day 15 these pre defined criteria are not met, subjects will be discharged and requested to collect a 24-hour sample of urine and/or faeces at home once per week and to deliver this to the clinical research unit in Zuidlaren. These weekly collections will be continued until the criteria are met. The total duration of the study will be approximately 5 - 6 weeks for each subject.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Orion Corporation, Orion Pharma ( Orion Corporation, Orion Pharma (Leena Lehtonen, Clinical study director) ) |
Study ID Numbers: | 3098004 |
Study First Received: | December 23, 2008 |
Last Updated: | March 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00817544 History of Changes |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
3098004 Healthy volunteers |
Healthy |