The purpose of this study is to: To determine the rate and routes of excretion of BIA 5-453 and the mass balance in urine and faeces
Monocentre, open, non-placebo-controlled, single-group, single-dose study Safety measurements (12-lead ECG, vital signs, blood chemistry and haematology) will be conducted before and after the study, adverse events will be monitored throughout the study. Subjects should be hospitalized the day before the administration until 264 hours thereafter.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
Each subject will receive a single oral dose of 100 μCi/ 3.7 MBq 14C labeled BIA 5-453 (600 mg).
Swiss Pharma Contract Ltd.
Allschwil, Switzerland
urinary excretion of BIA 5-453 associated radioactivity
following a single 600 mg oral dose labeled with 98 μCi of \[14C\]
Time frame: pre-dose, then it was collected from 0-4, 4-8, 8-24, 24-48, 48-72, 72-120, 120-168, 168-216, and 216-264 hours post-dose.
faecal excretion of BIA 5-453 associated radioactivity
baseline period. Following dose, each faeces sample was collected during the 264 hours post-dose period.
Time frame: following a single 600 mg oral dose labeled with 98 μCi of [14C]
amount of BIA 5-453 associated radioactivity present in the expired air
following a single 600 mg oral dose labeled with 98 μCi of \[14C\]
Time frame: baseline, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h 6h, 8h, 12h and 24h post-dose
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