Modelling pharmacokinetics and pharmacodynamics of the selective S1P₁ receptor modulator cenerimod in healthy subjects and systemic lupus erythematosus patients.

ABSTRACT:

Aims

Assessment of time to attain steady state as well as drug accumulation following long-term treatment with the selective sphingosine-1-phosphate 1 receptor modulator cenerimod and prediction of the incidence of low total lymphocyte (LY) counts. Differences in pharmacokinetics and pharmacodynamics based on demographic characteristics and between healthy subjects and systemic lupus erythematosus (SLE) patients were to be identified.

Methods

Data from 4 Phase I studies and 1 Phase II study were pooled to develop a population pharmacokinetic/pharmacodynamic model describing cenerimod concentration and its effect on LY count. Simulations addressed the objectives.

Results

Simulations of 365 days of treatment indicated a time to steady state of 49 days and changes in exp

SUBMITTER: Lott D 

PROVIDER: S-EPMC7098867 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature