Single-dose pharmacokinetics of atrasentan, an endothelin-A receptor antagonist

J Clin Pharmacol. 2001 Apr;41(4):397-403. doi: 10.1177/00912700122010258.

Abstract

The pharmacokinetics of 1, 10, 23.25, and 139.5 mg doses of atrasentan was assessed in a placebo-controlled, double-blind, single oral dose study in 24 healthy male subjects. Atrasentan was well tolerated. Atrasentan pharmacokinetics was linear in the 1 to 23.25 mg dose range, with some dose dependency in the highest dose group. Harmonic mean terminal half-life was similar across all dose groups (20-25 h). Apparent oral clearance was low (12 L/h) for the highest dose group compared with the other three dose groups (21-27 L/h). The apparent volume of distribution was large (approximately 6 L/kg), consistent with extensive tissue distribution.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase I
  • Randomized Controlled Trial

MeSH terms

  • Administration, Oral
  • Adolescent
  • Adult
  • Analysis of Variance
  • Blood Pressure / drug effects
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Endothelin Receptor Antagonists*
  • Endothelin-1 / drug effects
  • Half-Life
  • Humans
  • Male
  • Metabolic Clearance Rate
  • Middle Aged
  • Placebos

Substances

  • Endothelin Receptor Antagonists
  • Endothelin-1
  • Placebos