Population Pharmacokinetics of Cladribine in Patients with Multiple Sclerosis.

ABSTRACT:

Purpose

The aims of this study were to characterize the concentration-time course of cladribine (CdA) and its main metabolite 2-chloroadenine (CAde), estimate interindividual variability in pharmacokinetics (PK), and identify covariates explaining variability in the PK of CdA.

Methods

This population PK analysis was based on the combined dataset from four clinical studies in patients with multiple sclerosis (MS): three phase I studies, including one food and one drug-drug interaction study, and one phase III clinical study. Plasma and urine concentration data of CdA and CAde were modeled simultaneously.

Results

The analysis comprised a total of 2619 CdA and CAde plasma and urine concentration observations from 173 patients with MS who received an intravenous infusion

SUBMITTER: Savic RM 

PROVIDER: S-EPMC5591805 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature