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A Relative Bioavailability Study Evaluating Two New Encorafenib Formulations

NCT05446142 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2024-02-23

Study results available
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Summary

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

Conditions

  • Healthy

Interventions

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

Sponsors & Collaborators

  • Ono Pharmaceutical Co. Ltd

    collaborator INDUSTRY

  • Pierre Fabre Laboratories

    collaborator INDUSTRY

  • Pfizer

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-01
Primary Completion
2022-09-30
Completion
2022-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05446142 on ClinicalTrials.gov