Gastroesophageal Reflux DiseasePhase 1NCT01390714
Pharmacodynamic and Pharmacokinetic Study of E3710 Following Oral Administration to Healthy, Male, Japanese Subjects
A Phase 1 study testing E3710 in people with Gastroesophageal Reflux Disease, run by Eisai Co., Ltd. at 1 site in United States.
Trial summary
The purpose of this study is to investigate the pharmacodynamics (PD) and pharmacokinetics of E3710 following oral administration to Healthy Male Japanese Subjects Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- E3710
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Oct 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Cross-over, Pharmacodynamic and Pharmacokinetic Study of E3710 Following Oral Administration to Healthy, Male, Japanese Subjects
The purpose of this study is to investigate the pharmacodynamics (PD) and pharmacokinetics of E3710 following oral administration to Healthy Male Japanese Subjects
Read the 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
- Being tested
- E3710
- Keywords
- Proton Pump Inhibitors, Gastroesophageal Reflux Disease, pharmacokinetics, pharmacodynamics
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E3710Drug
Arm A:
- E3710 40 mg→RPZ 10 mg→E3710 20 mg
- RPZ 10 mg→E3710 20 mg→E3710 40 mg
- 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.
E3710Drug
Arm B:
- E3710 40 mg→E3710 80 mg→EPZ 40 mg
- E3710 80 mg→EPZ 40 mg →E3710 40 mg
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: E3710 |
| 2 | Experimental | Not described Receives: Drug: E3710 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacodynamic effect by ph monitoring will be evaluated.
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.
Measured: Day 1 and Day 5
Pharmacokinetics parameters Cmax will be calculated.
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.
Measured: 4 weeks
Pharmacokinetics parameter AUC will be calculated.
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Yen, Principal investigator, California Clinical Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01390714
- Sponsor's protocol ID
- E3710-A001-003
- Status last verified
- Mar 2012
- First submitted
- 28 Jun 2011
- Last updated
- 14 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Cross-over, Pharmacodynamic and Pharmacokinetic Study of E3710 Following Oral Administration to Healthy, Male, Japanese Subjects
- ClinicalTrials.gov ID
- NCT01390714
- Acronym / sponsor ID
- E3710-A001-003
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- Proton Pump Inhibitors, Gastroesophageal Reflux Disease, pharmacokinetics, pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 11 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: E3710 |
| 2 | Experimental | Drug: E3710 |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E3710Arm 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 | 1 |
| E3710Arm 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. | Drug | 2 |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Yen principal investigator
California Clinical Trials
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing E3710 in people with Gastroesophageal Reflux Disease, run by Eisai Co., Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacodynamic effect by ph monitoring will be evaluated. (time frame: Day 1 and Day 5). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2012.