This is an open-label, 2-cohort study to evaluate the absolute bioavailability, absorption, distribution, metabolism and excretion of TD-1473 in healthy male subjects. Subjects in cohort 1 will receive a single oral dose of TD-1473 and a single intravenous bolus dose of \[14C\]-TD-1473. Subjects in cohort 2 will receive a single oral dose of \[14C\]-TD-1473 only.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
20
(Intervention description included in arm description)
(Intervention description included in arm description)
(Intervention description included in arm description)
Celerion
Lincoln, Nebraska, United States
Maximum observed concentration (Cmax) in Plasma
Time frame: Up to 15 days
Time to maximum observed concentration (tmax) in Plasma
Time frame: Up to 15 days
Area under the concentration-time curve from hour 0 to the last measurable concentration (AUC0-last) in Plasma
Time frame: Up to 15 days
Area under the concentration-time curve extrapolated to infinity (AUC0-inf) in Plasma
Time frame: Up to 15 days
Apparent terminal elimination half-life (t1/2) in Plasma
Time frame: Up to 15 days
Apparent clearance (Cl/F) in Plasma
Time frame: Up to 15 days
Apparent volume of distribution (Vz/F) in Plasma
Time frame: Up to 15 days
Absolute bioavailability (%F) in Plasma
Time frame: Up to 15 days
Amount excreted in urine (Aeu) over the sampling interval in Urine
Time frame: Up to 15 days
Renal clearance (CLr) in Urine
Time frame: Up to 15 days
The percent excreted in urine (%Feu) in Urine
Time frame: Up to 15 days
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Amount excreted in feces (Aef) over the sampling interval in Feces
Time frame: Up to 15 days
The percent excreted in feces (%Fef)
Time frame: Up to 15 days