Pharmacokinetics, Excretion, and Mass Balance of [¹⁴ C]-Batefenterol Following a Single Microtracer Intravenous Dose (Concomitant to an Inhaled Dose) or Oral Dose of Batefenterol in Healthy Men.

ABSTRACT: Inhaled batefenterol is an investigational bifunctional molecule for the treatment of chronic obstructive pulmonary disease. The excretion balance and pharmacokinetics of batefenterol using [¹⁴ C]-radiolabeled drug administered orally and as intravenous (IV) infusion were assessed. In this 2-period, open-label study, 6 healthy male subjects received a single IV microtracer 1-hour infusion of 4 μg [¹⁴ C]-batefenterol concomitant with inhaled nonradiolabeled batefenterol (1200 μg) followed by oral [¹⁴ C]-batefenterol (200 μg) in period 2 after a 14-day washout. The primary end points included: the area under the concentration-time curve from time zero to last time of quantifiable concentration (AUC_0-t ); maximum observed concentration (C_max

SUBMITTER: Ambery C 

PROVIDER: S-EPMC6282586 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature