Pharmacokinetics and pharmacodynamics of CI-992 following intravenous and oral administration to cynomolgus monkeys

Biopharm Drug Dispos. 1998 Apr;19(3):185-91. doi: 10.1002/(sici)1099-081x(199804)19:3<185::aid-bdd92>3.0.co;2-c.

Abstract

The purpose of this study was to characterize CI-992 pharmacokinetics and pharmacokinetics/pharmacodynamics (PK/PD) in sodium deplete monkeys. Panels of monkeys were administered CI-992 as a 1 h intravenous infusions (0.1 and 1 mg kg-1) or as single oral doses (0, 10, 50, and 100 mg kg-1). Mean arterial blood pressure (MABP) was monitored and serial blood samples were collected up to 24 h postdose. Plasma CI-992 concentrations were quantitated by radioimmunoassay. Pharmacokinetic parameters were calculated by noncompartmental methods. PK/PD relationships were assessed by standard methods. Oral bioavailability of CI-992 in the monkeys was < 2%; steady-state volume of distribution was 0.67 L kg-1; clearance was 10.4 mL min-1 kg-1. Following oral administration, tmax generally occurred 6-9 h postadministration; plasma CI-992 concentrations increased with increasing dose between 10 and 50 mg kg-1, but did not change appreciably from 50 to 100 mg kg-1. After intravenous administration, change in MABP was correlated with plasma CI-992 concentration through an effect compartment model in which the maximum achievable effect was a 22 mm Hg decrease in MABP; the steady-state concentration which produced half the maximum effect was 11 ng mL-1. Following the 10 mg kg-1 oral dose the maximum decrease in MABP was 19.1 mm Hg; higher doses did not produce greater maximum response but increased the duration of action. In contrast to observations following intravenous administration, a trend for decreasing MABP with increasing plasma CI-992 was not apparent following oral CI-992 administration.

MeSH terms

  • Administration, Oral
  • Animals
  • Antihypertensive Agents / blood
  • Antihypertensive Agents / pharmacokinetics*
  • Antihypertensive Agents / pharmacology*
  • Biological Availability
  • Blood Pressure / drug effects
  • Dipeptides / blood
  • Dipeptides / pharmacokinetics*
  • Dipeptides / pharmacology*
  • Infusions, Intravenous
  • Macaca fascicularis
  • Male
  • Protease Inhibitors / blood
  • Protease Inhibitors / pharmacokinetics*
  • Protease Inhibitors / pharmacology*
  • Renin / antagonists & inhibitors
  • Sodium / deficiency

Substances

  • Antihypertensive Agents
  • Dipeptides
  • Protease Inhibitors
  • CI 992
  • Sodium
  • Renin