The purpose is to and to assess the mass balance recovery after a single oral dose of \[14C\]-BIA 9-1067 and to provide plasma, urine and faecal samples for metabolite profiling and structural identification.
This is an open-label, single-dose, single-period, non-randomised study in healthy male subjects. Subjects will be screened for eligibility to participate in the study between 28 and 2 days before dosing. Eligible subjects will be admitted to the clinical unit on the evening of the day before dosing (Day -1). Subjects will be dosed on the morning of Day 1 following an overnight fast of approximately 8 h. Blood, urine, faeces and expired air will be collected at predefined time points for mass balance and PK analysis. Subjects will remain resident in the clinic until the morning of Day 22, when they will be discharged as a group. Single dose administration on a single occasion. The estimated duration of the study from screening until the final return visit is approximately 3.5 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
1 × 100 mg capsule, Oral
Quotient Clinical
Ruddington, Nottingham, United Kingdom
Mass balance recovery of total radioactivity in all (urine, faeces and expired air combined) amount excreted (Ae) expressed as a percentage of the administered dose (%Ae)
Mass balance of total radioactivity in urine, faeces and expired air
Time frame: Urine and faeces: pre-dose,0,0.25,0.5,0.75,1,1.5, 2, 3, 4, 6,8,12,18,24,36,48,72,96,120,144,168,240,312,408,504,648 hours after dosing. Expired air: Pre-dose, 0.5,1,1.5,2,4,6,8,12,18,24,36,48,72,96,120,168,240,312,408,504 hours after dosing.
Mass balance recovery of total radioactivity in all (urine, faeces and expired air combined) cumulative recovery (CumAe) expressed as a percentage of the administered dose (Cum%Ae)
Mass balance of total radioactivity in urine, faeces and expired air
Time frame: Urine and faeces: pre-dose,0,0.25,0.5,0.75,1,1.5, 2, 3, 4, 6,8,12,18,24,36,48,72,96,120,144,168,240,312,408,504,648 hours after dosing. Expired air: Pre-dose, 0.5,1,1.5,2,4,6,8,12,18,24,36,48,72,96,120,168,240,312,408,504 hours after dosing.
Tlag: the elapsed time from dosing at which analyte was first quantifiable in a concentration vs time profile
Pharmacokinetic Data Analysis for BIA 9-1067 and its metabolites, BIA 9-1103 and BIA 9-4588
Time frame: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 120, 240, 408, 504 hours after dosing
Cmax: maximum observed concentration
Pharmacokinetic Data Analysis for BIA 9-1067 and its metabolites, BIA 9-1103 and BIA 9-4588
Time frame: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 120, 240, 408, 504 hours after dosing
Tmax: the time from dosing at which Cmax was apparent
Pharmacokinetic Data Analysis for BIA 9-1067 and its metabolites, BIA 9-1103 and BIA 9-4588
Time frame: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 120, 240, 408, 504 hours after dosing
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AUC0-t: area under the curve from 0 time to last measurable concentration
Pharmacokinetic Data Analysis for BIA 9-1067 and its metabolites, BIA 9-1103 and BIA 9-4588
Time frame: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 120, 240, 408, 504 hours after dosing