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.
- 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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