Case Study: Dose-response modeling informs Phase 2 ulcerative colitis study design

November 18, 2016

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Challenge

Our client had the following key questions which they wanted our pharmacometrics group to address for an upcoming phase 2 trial of their ulcerative colitis compound .

1) Can knowledge from pre-clinical and Phase 1 data inform on the optimal range of doses for an upcoming Phase 2 dose-ranging study?

2) How may the dose response observed in PD markers in Phase 1 healthy volunteers translate to the patient population?


The Cytel Solution:

Cytel pharmacometricians devised a modeling approach incorporating these elements :

  • Model Exposure-Response using PK and PD endpoints in healthy mice.
  • Modify model parameters for diseased mice and identify differences in response using both qualitative and quantitative measures.
  • Model the Exposure (Dose)-Response in the Phase 1 healthy volunteers.
  • Leverage all three models to create a predictive model for colitis patient PD responses.

Value Added

  • Predictions made by the modeling analyses were used to guide doses and assessments to be conducted in the Phase 2 study.

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