NCT01390714

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

An Open-label, Cross-over, Pharmacodynamic and Pharmacokinetic Study of E3710 Following Oral Administration to Healthy, Male, Japanese Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Eisai Co., Ltd. · Industry
• Sex: Male
• Age: 20 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Gastroesophageal Reflux Disease

Interventions

Type	Name	Description
DRUG	E3710	Arm A: 1. E3710 40 mg→RPZ 10 mg→E3710 20 mg 2. RPZ 10 mg→E3710 20 mg→E3710 40 mg 3. E3710 20 mg→E3710 40 mg→RPZ 10 mg Crossover study of E3710 40 mg, E3710 20 mg, and PRZ 10 mg, once daily, for 5 days, oral administration.
DRUG	E3710	Arm B: 1. E3710 40 mg→E3710 80 mg→EPZ 40 mg 2. E3710 80 mg→EPZ 40 mg →E3710 40 mg 3. EPZ 40 mg→E3710 40 mg→E3710 80 mg Crossover study of E3710 40 mg, E3710 80 mg, and EPZ 40 mg, once daily, for 5 days, oral administration.

Timeline

• Start date: 2011-07-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2011-07-11
• Last updated: 2012-03-14

Locations

1 site across 1 country: United States