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Kinase Inhibitor

Rabeprazole tablet for Healthy Subjects (ERBA Trial)

Phase 1
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 48 hours postdose
Awards & highlights

ERBA Trial Summary

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

ERBA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 48 hours postdose
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 48 hours postdose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area Under the Plasma Concentration-Time Profile From Time Zero to Extrapolated Infinite Time (AUCinf) Following Single Oral Doses of Encorafenib 75 mg Alone and With Rabeprazole
Area Under the Plasma Concentration-Time Profile From Time Zero to Last Quantifiable Concentration (AUClast) Following Single Oral Doses of Encorafenib 75 mg Alone and With Rabeprazole
Maximum Observed Plasma Concentration (Cmax) Following Single Oral Doses of Encorafenib 75 mg Alone and With Rabeprazole
Secondary outcome measures
Apparent Clearance (CL/F) Following Single Oral Doses of Encorafenib 75 mg Alone and With Rabeprazole
Apparent Volume of Distribution (Vz/F) Following Single Oral Doses of Encorafenib 75 mg Alone and With Rabeprazole
Number of Participants Meeting Vital Signs Categorical Criteria
+5 more

Side effects data

From 2022 Phase 1 trial • 18 Patients • NCT05446142
13%
Dyspepsia
13%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
75mg Encorafenib eMCC + 20 mg Rabeprazole, Fasted
75 mg Encorafenib eMCCL, Fasted
75 mg Encorafenib CAP, Fasted
75 mg Encorafenib eMCC, Fasted
75mg Encorafenib eMCCL + 20 mg Rabeprazole, Fasted

ERBA Trial Design

2Treatment groups
Experimental Treatment
Group I: Four Period Treatment Sequence: PPI Effect Second FormulationExperimental Treatment4 Interventions
Participants will receive a single encorafenib dose of the second formulation, a single encorafenib dose of the second formulation, a single encorafenib dose of the formulated capsule (CAP), and a single encorafenib dose of the second formulation after administration of 20 mg rabeprazole every evening for 5 days.
Group II: Four Period Treatment Sequence: PPI EffectExperimental Treatment4 Interventions
Participants will receive a single encorafenib dose formulation, a single encorafenib dose of the formulated capsule (CAP), and a single encorafenib dose of the formulation after administration of 20 mg rabeprazole every evening for 5 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Encorafenib
FDA approved
Encorafenib
FDA approved
Encorafenib
FDA approved
Rabeprazole
FDA approved

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

PfizerLead Sponsor
4,570 Previous Clinical Trials
10,916,008 Total Patients Enrolled
Ono Pharmaceutical Co. LtdIndustry Sponsor
154 Previous Clinical Trials
94,505 Total Patients Enrolled
Pierre Fabre LaboratoriesIndustry Sponsor
24 Previous Clinical Trials
44,076 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Connecticut
How old are they?
18 - 65
What site did they apply to?
New Haven Clinical Research Unit
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Relative Bioavailability Study Evaluating Two New Encorafenib Formulations
2022. "A Relative Bioavailability Study Evaluating Two New Encorafenib Formulations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05446142.
~7 spots leftby Apr 2025
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