Disposition of GDC-0879, a B-RAF kinase inhibitor in preclinical species

Xenobiotica. 2009 Sep;39(9):700-9. doi: 10.1080/00498250902991827.

Abstract

1. The pharmacokinetics and disposition of GDC-0879, a small molecule B-RAF kinase inhibitor, was characterized in mouse, rat, dog, and monkey. 2. In mouse and monkey, clearance (CL) of GDC-0879 was moderate (18.7-24.3 and 14.5 +/- 2.1 ml min(-1) kg(-1), respectively), low in dog (5.84 +/- 1.06 ml min(-1) kg(-1)) and high in rat (86.9 +/- 14.2 ml min(-1) kg(-1)). The volume of distribution across species ranged from 0.49 to 1.9 l kg(-1). Mean terminal half-life values ranged from 0.28 h in rats to 2.97 h in dogs. Absolute oral bioavailability ranged from 18% in dog to 65% in mouse. 3. Plasma protein binding of GDC-0879 in mouse, rat, dog, monkey, and humans ranged from 68.8% to 81.9%. 4. In dog, the major ketone metabolite (G-030748) of GDC-0879 appeared to be formation rate-limited. 5. Based on assessment in dogs, the absorption of GDC-0879 appeared to be sensitive to changes in gut pH, food and salt form (solubililty), with approximately three- to four-fold change in areas under the curve (AUCs) observed.

MeSH terms

  • Animals
  • Blood Proteins / metabolism
  • Dogs
  • Drug Evaluation, Preclinical
  • Female
  • Half-Life
  • Humans
  • Indenes / administration & dosage
  • Indenes / chemistry
  • Indenes / pharmacokinetics*
  • Macaca fascicularis
  • Male
  • Metabolic Clearance Rate
  • Mice
  • Protein Binding
  • Protein Kinase Inhibitors / administration & dosage
  • Protein Kinase Inhibitors / chemistry
  • Protein Kinase Inhibitors / pharmacokinetics*
  • Proto-Oncogene Proteins B-raf / antagonists & inhibitors*
  • Pyrazoles / administration & dosage
  • Pyrazoles / chemistry
  • Pyrazoles / pharmacokinetics*
  • Rats
  • Rats, Sprague-Dawley

Substances

  • 2-(4-(1-(hydroxyimino)-2,3-dihydro-1H-inden-5-yl)-3-(pyridin-4-yl)-1H-pyrazol-1-yl)ethan-1-ol
  • Blood Proteins
  • Indenes
  • Protein Kinase Inhibitors
  • Pyrazoles
  • Proto-Oncogene Proteins B-raf