Rabeprazole tablet for Healthy Subjects (HS)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
New Haven Clinical Research Unit, New Haven, CT
Healthy Subjects (HS)
Rabeprazole tablet - Drug
Eligibility
18+
All Sexes
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Study Summary

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

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Healthy Subjects (HS)

Study Objectives

15 Primary · 24 Secondary · Reporting Duration: Baseline through Period 4 (period 4 is defined as Day 1, Pre-dose, hours 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 48)

Baseline through Period 4
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Day 1
Number of Participants With Electrocardiogram (ECG) Abnormalities
Day 1
Plasma AUCinf of the first formulation after 5 days of 20 mg daily rabeprazole dosing
Plasma AUCinf of the second formulation after 5 days of 20 mg daily rabeprazole dosing
Plasma AUClast of the first formulation after 5 days of 20 mg daily rabeprazole dosing
Plasma AUClast of the second formulation after 5 days of 20 mg daily rabeprazole dosing
Plasma Cmax of the first formulation after 5 days of 20 mg daily rabeprazole dosing
Plasma Cmax of the second formulation after 5 days of 20 mg daily rabeprazole dosing
Day 1
Plasma AUCinf after administration of the CAP (encorafenib formulated capsule) formulation
Plasma AUClast after administration of the CAP formulation
Plasma Cmax after administration of the CAP formulation
Day 1
Apparent Oral Clearance (CL/F) after administration of the CAP formulation
Apparent Volume of Distribution (Vz/F) after administration of the CAP formulation
Plasma Decay Half-Life (t1/2) after administration of the CAP formulation
Time to Reach Maximum Observed Plasma Concentration (Tmax) after administration of the CAP formulation
Day 1
Apparent Oral Clearance (CL/F) after administration of the first formulation after 5 days of 20mg daily rabeprazole dosing
Apparent Oral Clearance (CL/F) after administration of the second formulation after 5 days of 20mg daily rabeprazole dosing
Apparent Volume of Distribution (Vz/F) after administration of the first formulation after 5 days of 20mg daily rabeprazole dosing
Apparent Volume of Distribution (Vz/F) after administration of the second formulation after 5 days of 20mg daily rabeprazole dosing
Plasma Decay Half-Life (t1/2) after administration of the first formulation after 5 days of 20mg daily rabeprazole dosing
Plasma Decay Half-Life (t1/2) after administration of the second formulation after 5 days of 20mg daily rabeprazole dosing
Time to Reach Maximum Observed Plasma Concentration (Tmax) after administration of the first formulation after 5 days of 20mg daily rabeprazole dosing
Time to Reach Maximum Observed Plasma Concentration Plasma after administration of the second formulation after 5 days of 20mg daily rabeprazole dosing
Day 1
Apparent Oral Clearance (CL/F) after administration of the first formulation
Apparent Oral Clearance (CL/F) after administration of the second formulation
Apparent Volume of Distribution (Vz/F) after administration of the first formulation
Apparent Volume of Distribution (Vz/F) after administration of the second formulation
Plasma AUCinf after administration of the first formulation
Plasma AUCinf of the second formulation
Plasma AUClast after administration of the first formulation
Plasma AUClast after administration of the second formulation
Plasma Cmax after administration of the first formulation
Plasma Cmax after administration of the second formulation
Plasma Decay Half-Life (t1/2) after administration of the first formulation
Plasma Decay Half-Life (t1/2) after administration of the second formulation
Time to Reach Maximum Observed Plasma Concentration (Tmax) after administration of the first formulation
Time to Reach Maximum Observed Plasma Concentration (Tmax) after administration of the second formulation
Time the participant provides informed consent through and including a minimum of 28 calendar days after the last administration of the study intervention.
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Day 28
Number of Participants With Laboratory Test Abnormalities

Trial Safety

Safety Progress

1 of 3

Other trials for Healthy Subjects (HS)

Trial Design

2 Treatment Groups

Four Period Treatment Sequence: PPI Effect
1 of 2
Four Period Treatment Sequence: PPI Effect Second Formulation
1 of 2
Experimental Treatment

18 Total Participants · 2 Treatment Groups

Primary Treatment: Rabeprazole tablet · No Placebo Group · Phase 1

Four Period Treatment Sequence: PPI EffectExperimental Group · 4 Interventions: Encorafenib first formulation, Rabeprazole tablet, Encorafenib second formulation, Encorafenib capsule formulation (CAP) · Intervention Types: Drug, Drug, Drug, Drug
Four Period Treatment Sequence: PPI Effect Second FormulationExperimental Group · 4 Interventions: Encorafenib first formulation, Rabeprazole tablet, Encorafenib second formulation, Encorafenib capsule formulation (CAP) · Intervention Types: Drug, Drug, Drug, Drug

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline through period 4 (period 4 is defined as day 1, pre-dose, hours 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 48)
Closest Location: New Haven Clinical Research Unit · New Haven, CT
Photo of New Haven  1Photo of New Haven  2Photo of New Haven  3
2015First Recorded Clinical Trial
41 TrialsResearching Healthy Subjects (HS)
47 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are capable of giving informed consent.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.