An Open-label Study to Assess the Absorption, Distribution, Metabolism and Excretion, Including the Mass Balance, of [14C] Labeled BIA 5-1058 and Metabolites Following a Single Oral Dose Administration in Healthy Male Subjects
Abstract
the purpose of this study is:
* to determine the rate and routes of excretion of BIA 5-1058 and the mass balance in urine, feces and exhaled air, after a single oral dose of 400 mg 14C labeled BIA 5 1058 containing 3.7 Megabecquerel (MBq) of radiocarbon;
* to determine the pharmacokinetics (PK) of total radioactivity (TRA) in plasma and whole blood and to assess the blood-to-plasma ratio;
* to determine the PK of BIA 5-1058 and its metabolites in plasma.
Conditions: Pulmonary Arterial Hypertension.
Primary outcome: Cmax - Maximum observed plasma concentration; Tmax - Time to attain maximum observed plasma concentration; AUC0-t Area under the plasma concentration-time curve up to time t, where t is the last point with concentrations above the lower limit of quantitation (LLOQ); AUC0-inf - Area under the plasma concentration-time curve from time 0 extrapolated to infinity; t1/2 - Elimination half-life; CLR - Renal clearance; Aeurine - Cumulative amount excreted in urine; Ae feces - Cumulative amount excreted in feces; Aeair - Cumulative amount excreted in exhaled air; Aetotal - Total amount excreted, calculated as Aeurine + Aefeces + Aeair; TRA t1/2 plasma; TRA t1/2 urine; TRA t1/2 feces.
Enrollment: 15 participants.
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 15 participants or records.
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