Pharmacodynamic and Pharmacokinetic Study of E3710 Following Oral Administration to Healthy, Male, Japanese Subjects

Phase 1

Completed

• Conditions: Gastroesophageal Reflux Disease
• Interventions: Drug: E3710

• Registration Number: NCT01390714
• Lead Sponsor: Eisai Co., Ltd.

Brief Summary

The purpose of this study is to investigate the pharmacodynamics (PD) and pharmacokinetics of E3710 following oral administration to Healthy Male Japanese Subjects

Detailed Description

This study will be conducted in healthy, male, Japanese subjects using an open-label, randomized, crossover design with comparison under multiple oral doses of E3710. Rabeprazole or Esomeprazole will be used in this study as marketed comparators. In each arm, pharmacodynamics will be measured in regard to intragastric pH. The measurements will be recorded using a pH probe with esophageal measurement capability for 24 hours post-dose. Pharmacokinetics measurements will also be conducted in all dosing stages for collecting serial blood samples.

Study Timeline

• Study First Submitted: 2011-06-28
• Study Start: 2011-07
• Study First Submitted QC: 2011-07-07
• Study First Posted: 2011-07-11
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-13
• Last Update Posted: 2012-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	E3710	-
2	E3710	-

Primary Outcome Measures

Name	Time	Method
Pharmacodynamic effect by ph monitoring will be evaluated.	Day 1 and Day 5	Summary statistics of the measurements and changes from pre-dose values to post-dose values of intragastric pH 1-, pH 2-, pH 3-, pH 4-, pH 5-, and pH 6 holding time, mean of the intragastric pH and median of intragastric pH are to be calculated by dose. In addition, the mean and median intragastric pH for the hours 1-14 and 14-24 (8:00-22:00 and 22:00-8:00) should be calculated for baseline and each pH-recording period.
Pharmacokinetics parameters Cmax will be calculated.	4 weeks	Summary statistics of E3710/RPZ/EPZ pharmacokinetic parameters on Day 1 and Day 5 of administration are to be calculated by dose. Relationship of Cmax to dose of E3710 is to be examined.
Pharmacokinetics parameter AUC will be calculated.	4 weeks	Summary statistics of E3710/RPZ/EPZ pharmacokinetic parameters on Day 1 and Day 5 of administration are to be calculated by dose. Relationship of AUC to dose of E3710 is to be examined.