Pharmacodynamic and Pharmacokinetic Study of E3710 Following Oral Administration to Healthy, Male, Japanese Subjects
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|ClinicalTrials.gov Identifier: NCT01390714|
Recruitment Status : Completed
First Posted : July 11, 2011
Last Update Posted : March 14, 2012
|Condition or disease||Intervention/treatment||Phase|
|Gastroesophageal Reflux Disease||Drug: E3710||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Cross-over, Pharmacodynamic and Pharmacokinetic Study of E3710 Following Oral Administration to Healthy, Male, Japanese Subjects|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||October 2011|
Crossover study of E3710 40 mg, E3710 20 mg, and PRZ 10 mg, once daily, for 5 days, oral administration.
Crossover study of E3710 40 mg, E3710 80 mg, and EPZ 40 mg, once daily, for 5 days, oral administration.
- Pharmacodynamic effect by ph monitoring will be evaluated. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01390714
|United States, California|
|Glendale, California, United States|
|Principal Investigator:||Mark Yen||California Clinical Trials|