NCT05446142

A Relative Bioavailability Study Evaluating Two New Encorafenib Formulations

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Encorafenib capsule formulation (CAP)	A single encorafenib dose of the CAP formulation
DRUG	Encorafenib first formulation	first formulation
DRUG	Encorafenib second formulation	second formulation
DRUG	Rabeprazole tablet	Proton-pump inhibitor

Timeline

• Start date: 2022-07-01
• Primary completion: 2022-09-30
• Completion: 2022-09-30
• First posted: 2022-07-06
• Last updated: 2024-02-23
• Results posted: 2024-02-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study