- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
California
-
Glendale, California, United States
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
- Subjects who received a full explanation about objectives and contents of this study and provided written consent to participate in this study by their own free will before the start of screening.
- Japanese, healthy, male adults, 20-40 years of age on the day of consent.
- Japanese subjects must be first generation Japanese (born in Japan of Japanese parents and Japanese grandparents), must have lived no more than 5 years outside of Japan and must not have changed their life style or habits, including diet, while living outside of Japan.
- CYP2C19 homo or heterozygous extensive metabolizers.
- Subjects who have no current infection with Helicobacter pylori (H. pylori).
- Subjects with body mass index (BMI) 18.5-25.0 kg/m2 at the time of screening.
- Subjects who received screening examination within 4 weeks before entering the Phase I unit in Stage 1 and were judged to be eligible for this study by the investigator.
Exclusion Criteria
- Likely allergy or sensitivity to any components of E3710 based on known allergies to drugs of the same class (e.g. proton pumps inhibitors, specifically RPZ or EPZ) or which in the opinion of the Principal Investigator might increase the potential for adverse events.
- Subjects with present or previous history of drug allergy, food allergy or clinically problematic allergy (e.g. chronic asthma or urticaria).
- Subjects with diseases that may affect evaluation of the study drug such as gastrointestinal, hepatic, renal, respiratory, endocrine, blood, nervous, mental or cardiac vascular diseases or congenital metabolic disorders at the time of screening or within 4 weeks before hospitalization in each stage of the study.
- Subjects with history of surgical therapies (such as resection of the liver, the kidney or the digestive tracts) that may influence pharmacokinetics of the study drug.
- Subjects who had 10% or more of body weight changes during a period from screening to Day 1 of hospitalization in each stage of the study.
- Subjects who had beverages containing caffeine (such as coffee, tea, chocolate or cola) within 72 hours before hospitalization in each stage of the study.
- Subjects who had grapefruit juice or food and drinks containing grapefruit within 72 hours before hospitalization in each stage of the study.
- Subjects who had alcoholic beverages within 72 hours before hospitalization in each stage of the study.
- Subjects who cannot quit smoking during hospitalization.
- Subjects who performed vigorous exercise or hard labor (more than 1 hour in a day or 5 days or more in a week) within 2 weeks before hospitalization in each stage of the study.
- Subjects who are found to have abnormal clinical symptoms or organ function disorders requiring medical treatment in examinations of medical history, symptoms and signs, vital signs, ECG or laboratory tests.
- Subjects with QTC longer than 450 msec in 12-lead electrocardiography (Bazett's method).
- Subjects with history of alcohol or drug abuse, who are suspected to have such the history or who have positive reaction in urinary drug test at the time of screening or hospitalization of the study.
- Subjects who used any ethical drugs within 4 weeks before hospitalization in each stage of the study *.
- Subjects who took any OTC drugs (including PPIs and H2-receptor antagonists), antacids, nutrients, vitamin preparations or preparations containing herb (including Chinese medicines and food products) within one week before hospitalization in each stage of the study. However, for the herb preparations, which are known to induce cytochrome P450, drug metabolizing enzyme (e.g. preparations and food products containing St. John's wort), subjects who took such the preparations within 4 weeks before hospitalization in each stage of the study.
- Subjects who used any other investigational drugs or investigational medical equipment within 16 weeks before hospitalization in each stage of the study.
- Subjects who received blood transfusions within 12 weeks before hospitalization in each stage of the study, or who donated 400 mL or more of whole blood within 12 weeks or 200 mL or more of whole blood within 4 weeks before hospitalization in each stage of the study.
- Subjects who had any infections requiring medical treatments within 4 weeks before hospitalization in each stage of the study.
- Subjects who are positive for hepatitis B surface antigen (HBs antigen), hepatitis C virus (HCV) antibody or qualitative test for syphilis.
- Subjects who were diagnosed as acquired immunodeficiency syndrome (AIDS) or who had positive reaction for human immunodeficiency virus (HIV).
- Subjects who are not willing to observe the rules of this study or who cannot observe them.
- Patients who were judged to be inappropriate for participation in this study by the investigator or subinvestigator. *: Excluding drugs prescribed by the investigator in case of necessity for treatment of adverse events after hospitalization.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
Arm A:
Crossover study of E3710 40 mg, E3710 20 mg, and PRZ 10 mg, once daily, for 5 days, oral administration. Arm B:
Crossover study of E3710 40 mg, E3710 80 mg, and EPZ 40 mg, once daily, for 5 days, oral administration. |
Experimental: 2
|
Arm A:
Crossover study of E3710 40 mg, E3710 20 mg, and PRZ 10 mg, once daily, for 5 days, oral administration. Arm B:
Crossover study of E3710 40 mg, E3710 80 mg, and EPZ 40 mg, once daily, for 5 days, oral administration. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Day 1 and Day 5
|
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.
|
4 weeks
|
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.
|
4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mark Yen, California Clinical Trials
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E3710-A001-003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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