Healthy Male Volunteers Clinical Trial
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 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
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.
;
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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