Population pharmacokinetics of TLD-1, a novel liposomal doxorubicin, in a phase I trial.

ABSTRACT:

Study objectives

TLD-1 is a novel pegylated liposomal doxorubicin (PLD) formulation aiming to optimise the PLD efficacy-toxicity ratio. We aimed to characterise TLD-1's population pharmacokinetics using non-compartmental analysis and nonlinear mixed-effects modelling.

Methods

The PK of TLD-1 was analysed by performing a non-compartmental analysis of longitudinal doxorubicin plasma concentration measurements obtained from a clinical trial in 30 patients with advanced solid tumours across a 4.5-fold dose range. Furthermore, a joint parent-metabolite PK model of doxorubicin_entrapped, doxorubicin_free, and metabolite doxorubicinol was developed. Interindividual and interoccasion variability around the typical PK parameters and potential covariates to explain

SUBMITTER: Mc Laughlin AM 

PROVIDER: S-EPMC11420315 | biostudies-literature | 2024 Sep

REPOSITORIES: biostudies-literature