Population pharmacokinetics of naloxegol in a population of 1247 healthy subjects and patients.

ABSTRACT:

Aims

Naloxegol, a polyethylene glycol conjugated derivative of the opioid antagonist naloxone, is in clinical development for treatment of opioid-induced constipation (OIC). The aim of the study was to develop a population pharmacokinetic model describing the concentration vs. time profile of orally administered naloxegol, and determine the impact of pre-specified demographic and clinical factors and concomitant medication on population estimates of apparent clearance (CL/F) and apparent central compartment volume of distribution (Vc /F).

Methods

Analysis included 12,844 naloxegol plasma concentrations obtained from 1247 healthy subjects, patients with non-OIC and patients with OIC in 14 phase 1, 2b and 3 clinical studies. Pharmacokinetic analysis used the non-linear mixed e

SUBMITTER: Al-Huniti N 

PROVIDER: S-EPMC4693583 | biostudies-literature | 2016 Jan

REPOSITORIES: biostudies-literature