Absorption, Distribution, Metabolism, and Excretion of [¹⁴C]-Volixibat in Healthy Men: Phase 1 Open-Label Study.

ABSTRACT:

Background and objectives

Volixibat is a potent inhibitor of the apical sodium-dependent bile acid transporter in development for the treatment of nonalcoholic steatohepatitis. This phase 1, open-label study investigated the absorption, distribution, metabolism, and excretion of [¹⁴C]-volixibat in heathy men.

Methods

Eligible men (n = 8) aged 18-50 years (body mass index 18.0-30.0 kg/m²; weight >50 kg) received a single oral dose of [¹⁴C]-volixibat 50 mg containing ~5.95 µCi radioactivity. The primary objectives were to assess the pharmacokinetics of [¹⁴C]-volixibat and to determine the total radioactivity in whole blood, plasma, urine, and feces at pre-selected time points over 6 days. The secondary objectives were to characterize

SUBMITTER: Siebers N 

PROVIDER: S-EPMC5794849 | biostudies-literature | 2018 Feb

REPOSITORIES: biostudies-literature