To determine the absorption, metabolism and excretion of BIA 9-1067.
Monocentre, open, non-placebo-controlled, single-group, single-dose study
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
90 µCi (3.33 MBq) \[14C\]-labeled of 100 mg BIA 9-1067 (single-dose).
Covance Basel Research Unit AG (formerly Swiss Pharma Contract Ltd)
Allschwil, Base, Switzerland
Maximum Plasma Concentration (Cmax)
Whole blood samples for total radioactivity analysis, plasma samples for total radioactivity analysis, and plasma samples for analysis of BIA 9-1067 and its metabolites
Time frame: 24 hours:pre-dose and 1, 1.75, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose
Time to Reach Maximum Plasma Concentration (Tmax)
Whole blood samples for total radioactivity analysis, plasma samples for total radioactivity analysis, and plasma samples for analysis of BIA 9-1067 and its metabolites
Time frame: 24 hours at the following times: pre-dose and 1, 1.75, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose
Area Under the Plasma-concentration Time Curve Until the Last Quantifiable Sampling Point (AUC0-t)
Whole blood samples for total radioactivity analysis, plasma samples for total radioactivity analysis, and plasma samples for analysis of BIA 9-1067 and its metabolites
Time frame: 24 hours at the following times: pre-dose and 1, 1.75, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose
Area Under the Plasma-concentration Time Curve With Extrapolation to Infinity (AUC0-∞)
Whole blood samples for total radioactivity analysis, plasma samples for total radioactivity analysis, and plasma samples for analysis of BIA 9-1067 and its metabolites
Time frame: 24 hours at the following times: pre-dose and 1, 1.75, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose
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