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A Relative Bioavailability Study Evaluating Two New Encorafenib Formulations — ERBA  

Healthy Clinical Trial

Official title:
A PHASE 1, RANDOMIZED, OPEN-LABEL STUDY IN HEALTHY PARTICIPANTS TO ESTIMATE THE BIOAVAILABILITY OF TWO NEW ENCORAFENIB FORMULATIONS RELATIVE TO THE CURRENT FORMULATION AND TO EVALUATE THE EFFECT OF A PROTON-PUMP INHIBITOR ON ENCORAFENIB PLASMA PHARMACOKINETICS

Clinical Trial Summary

Relative bioavailability study to evaluate the pharmacokinetics of two new encorafenib formulations

Clinical Trial Description

In order to decrease the size of the current formulated encorafenib capsule and improve the physical stability, 2 new encorafenib tablet formulations have been developed. This study is intended to select the optimal tablet formulation for commercialization based on the tablet pharmacokinetics. A preliminary assessment of the effect of a proton-pump inhibitor on the pharmacokinetics of the 2 encorafenib tablet formulations will also be conducted to assist in the formulation selection. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05446142
Study type Interventional
Source Pfizer
Contact
Status Completed
Phase Phase 1
Start date July 1, 2022
Completion date September 30, 2022
View Details
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