Elucidation of the biochemical basis for a clinical drug-drug interaction between atorvastatin and 5-(N-(4-((4-ethylbenzyl)thio)phenyl)sulfamoyl)-2-methyl benzoic acid (CP-778875), a subtype selective agonist of the peroxisome proliferator-activated receptor alpha

Xenobiotica. 2013 Nov;43(11):963-72. doi: 10.3109/00498254.2013.791004. Epub 2013 Apr 30.

Abstract

1. 5-(N-(4-((4-ethylbenzyl)thio)phenyl)sulfamoyl)-2-methyl benzoic acid (CP-778875), an agonist of the peroxisome proliferator-activated receptor alpha, has been evaluated in the clinic to treat dyslipidemia and type 2 diabetes mellitus. Herein, we investigate the effect of CP-778875 on the pharmacokinetics of atorvastatin acid and its metabolites in humans. 2. The study incorporated a fixed-sequence design conducted in two groups. Group A was designed to estimate the effects of multiple doses of CP-778875 on the single dose pharmacokinetics of atorvastatin. Subjects in group A (n = 26) received atorvastatin (40 mg) on days 1 and 9 and CP-778875 (1.0 mg QD) on days 5-12. Group B was designed to examine the effects of multiple doses of atorvastatin on the single dose pharmacokinetics of CP-778875. Subjects in group B (n = 29) received CP-778875 (0.3 mg) on days 1 and 9 and atorvastatin (40 mg QD) on days 5-12. 3. Mean maximum serum concentration (Cmax) and area under the curve of atorvastatin were increased by 45% and 20%, respectively, upon co-administration with CP-778875. Statistically significant increases in the systemic exposure of ortho- and para-hydroxyatorvastatin were also observed upon concomitant dosing with CP-778875. CP-778875 pharmacokinetics, however, were not impacted upon concomitant dosing with atorvastatin. 4. Inhibition of organic anion transporting polypeptide 1B1 by CP-778875 (IC50 = 2.14 ± 0.40 μM) could be the dominant cause of the pharmacokinetic interaction as CP-778875 did not exhibit significant inhibition of cytochrome P450 3A4/3A5, multidrug resistant protein 1 or breast cancer resistant protein, which are also involved in the hepatobiliary disposition of atorvastatin.

MeSH terms

  • Animals
  • Atorvastatin
  • Benzoates / chemistry
  • Benzoates / pharmacology*
  • Benzoic Acid / chemistry
  • Benzoic Acid / pharmacology*
  • Cytochrome P-450 Enzyme Inhibitors
  • Cytochrome P-450 Enzyme System / metabolism
  • Dogs
  • Drug Interactions
  • HEK293 Cells
  • Heptanoic Acids / blood
  • Heptanoic Acids / pharmacokinetics
  • Heptanoic Acids / pharmacology*
  • Humans
  • Hydroxylation / drug effects
  • Madin Darby Canine Kidney Cells
  • Membrane Transport Proteins / metabolism
  • Oxidation-Reduction / drug effects
  • PPAR alpha / agonists*
  • Pyrroles / blood
  • Pyrroles / pharmacokinetics
  • Pyrroles / pharmacology*
  • Sulfonamides / chemistry
  • Sulfonamides / pharmacology*
  • Time Factors

Substances

  • 5-(N-(4-((4-ethylbenzyl)thio)phenyl)sulfamoyl)-2-methylbenzoic acid
  • Benzoates
  • Cytochrome P-450 Enzyme Inhibitors
  • Heptanoic Acids
  • Membrane Transport Proteins
  • PPAR alpha
  • Pyrroles
  • Sulfonamides
  • Benzoic Acid
  • Cytochrome P-450 Enzyme System
  • Atorvastatin