A Study to Evaluate the Effect on 24-hour, Intragastric pH of RAB ER 50-mg Capsules Compared With Esomeprazole (Nexium) 40 mg Capsules and Rabeprazole (Aciphex) 20-mg Tablets

Study Overview
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Brief Summary
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This will be a randomized, open-label, single-center, 3-way crossover study in healthy subjects who are confirmed to be Helicobacter pylori (H. pylori)-negative. The study will consist of 3 study periods separated by a washout period of at least 7 days. Subjects will receive study drugs once daily for 5 days. Barring any safety concerns, subjects will be discharged from the study on Day 6 of Period 3 after completion of discharge procedures.

Official Title
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A Randomized, Open-Label, Three-Way Crossover Study to Evaluate the Effect on 24-hour, Intragastric pH Following Daily Oral Dose Administration of RAB ER 50-mg Capsules Compared With Esomeprazole (Nexium) 40-mg Capsules and Rabeprazole (Aciphex) 20-mg Tablets to H. Pylori-Negative Healthy Subjects in a 5-day Treatment Regimen

Conditions
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Healthy

Intervention / Treatment
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* Drug: E3810
* Drug: Aciphex (rabeprazole)
* Drug: Nexium (esomeprazole)


Participation Criteria
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Eligibility Criteria
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Key inclusion: Healthy male and female subjects, including women of child-bearing potential, aged 18 to 55 years, inclusive Subjects who are able to tolerate the insertion and placement of a pH probe on 2 occasions per study period (Day -1 and Day 5) Key Exclusion: Subjects who are H. pylori-positive Subjects who have a history of any gastrointestinal disorder or surgery likely to influence drug absorption (e.g., history of gastric resection) Known hypersensitivity to rabeprazole, esomeprazole, or related compounds or any ingredient in the formulations Other standard clinical pharmacology exclusion criteria for healthy volunteers

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: E3810<br>* RAB ER 50 mg capsule once per day on Days 1-5<br>|
| Active Comparator: 2<br> | Drug: Aciphex (rabeprazole)<br>* Aciphex (rabeprazole) 20 mg tablet once per day on Days 1-5<br>|
| Active Comparator: 3<br> | Drug: Nexium (esomeprazole)<br>* Nexium (esomeprazole) 40 mg capsule once per day on Days 1-5<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of time that intragastric pH remains >4 |  | 24-hr period post-dose on Day 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of day- and night-time periods with intragastric pH >4 |  | Days 1 and 5 | 
| Number and duration of nocturnal acid breakthrough (NAB) episodes |  | Days 1 and 5 | 
| Proportion of subjects with nocturnal acid breakthrough (NAB) episodes |  | Days 1 and 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rabeprazole, esomeprazole, h. pylori-negative, nocturnal acid breakthrough, intragastric pH, PK/PD, effect on gastric pH in healthy, H. pylori-Negative subjects