Excretion Balance and Metabolism After a Single Oral Dose of 14C-Labelled ORM-12741 (ALMAS)
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
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- The excretion balance of total 14C-radioactivity after a single oral dose of 14C-ORM-12741 [ Time Frame: Total 14C-radioactivity in faeces and urine until pre-defined criteria are met. The total duration of the study will be approximately 5 - 6 weeks for each subject. ] [ Designated as safety issue: No ]
- To gain further information on the safety of ORM-12741 [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2009|
|Study Completion Date:||March 2009|
|Primary Completion Date:||February 2009 (Final data collection date for primary outcome measure)|
3 mg of ORM-12741 as a single dose. Contains 0.73 mg (2.5 MBq) 14C labelled ORM-12741
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.