HealthyPhase 2NCT01202071
A Clinical Pharmacological Study of Rabeprazole Sodium in Japanese Healthy Adult Male Volunteers (Study E3810)
A Phase 2 study testing Rabeprazole sodium, 5 mg Tablets, Rabeprazole sodium, 10 mg Tablets and Rabeprazole sodium, 20 mg Tablets in people with Healthy, run by Eisai Co., Ltd. at 1 site in Japan.
Trial summary
The purpose of this study is to compare the pharmacodynamics/pharmacokinetics of 5 mg, 10 mg, 20 mg and 40 mg of Rabeprazole sodium (E3810) when administered repeatedly once daily for 5 days to healthy adult male Japanese participants. 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
- Healthy
- What is being tested?
- Rabeprazole sodium, 5 mg Tablets, Rabeprazole sodium, 10 mg Tablets and Rabeprazole sodium, 20 mg Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteJapan
- Study dates
- Sep 2010to Dec 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- healthy adult Japanese male between the age of 20-40
- body mass index between 18.5-25
Who cannot join
- clinically significant abnormal physical examination, vital signs or electrocardiogram
- use of any prescription medication, antacid, nutritional supplement, vitamin preparation, or herb-containing drug within the previous 4 weeks
- use of any non-prescription medication within the previous 1 week
- history of drug or alcohol abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Pharmacological Study of Rabeprazole Sodium in Japanese Healthy Adult Male Volunteers
The purpose of this study is to compare the pharmacodynamics/pharmacokinetics of 5 mg, 10 mg, 20 mg and 40 mg of Rabeprazole sodium (E3810) when administered repeatedly once daily for 5 days to healthy adult male Japanese participants. This was a single-center, open-label, randomized, four-treatment, four-way crossover study.
- Conditions
- Healthy
- Being tested
- Rabeprazole sodium, 5 mg Tablets, Rabeprazole sodium, 10 mg Tablets, Rabeprazole sodium, 20 mg Tablets, Rabeprazole sodium, 40 mg Tablets (two 20 mg Tablets)
- Keywords
- Rabeprazole, proton pump inhibitor, pharmacokinetics, pharmacodynamics, healthy adult male Japanese subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rabeprazole sodium, 5 mg TabletsDrug
Also called E3810, E3810-J081-040
Rabeprazole sodium Tablets, 5 mg administered for 5 days.
Day 1 and Day 5: participants received a single dose with 200 mL of water in the morning while fasting for 10 hours or longer.
Day 2 to Day 4: participants received a single dose with 200 mL of water >= 2 hours after the completion of breakfast.
Rabeprazole sodium, 10 mg TabletsDrug
Also called E3810, E3810-J081-040
Rabeprazole sodium Tablets, 10 mg administered for 5 days.
Day 1 and Day 5: participants received a single dose with 200 mL of water in the morning while fasting for 10 hours or longer.
Day 2 to Day 4: participants received a single dose with 200 mL of water >= 2 hours after the completion of breakfast.
Rabeprazole sodium, 20 mg TabletsDrug
Also called E3810, E3810-J081-040
Rabeprazole sodium Tablets, 20 mg administered for 5 days.
Day 1 and Day 5: participants received a single dose with 200 mL of water in the morning while fasting for 10 hours or longer.
Day 2 to Day 4: participants received a single dose with 200 mL of water >= 2 hours after the completion of breakfast.
Rabeprazole sodium, 40 mg Tablets (two 20 mg Tablets)Drug
Also called E3810, E3810-J081-040
Rabeprazole sodium Tablets, 40 mg (two 20 mg Tablets) administered for 5 days.
Day 1 and Day 5: participants received a single dose with 200 mL of water in the morning while fasting for 10 hours or longer.
Day 2 to Day 4: participants received a single dose with 200 mL of water, >=2 hours after the completion of breakfast.
| Study group | Role | What they receive |
|---|---|---|
| Rabeprazole sodium Tablets, 5 mg | Experimental | Not described Receives: Drug: Rabeprazole sodium, 5 mg Tablets |
| Rabeprazole sodium Tablets, 10 mg | Experimental | Not described Receives: Drug: Rabeprazole sodium, 10 mg Tablets |
| Rabeprazole sodium Tablets, 20 mg | Experimental | Not described Receives: Drug: Rabeprazole sodium, 20 mg Tablets |
| Rabeprazole sodium Tablets, 40 mg (two 20 mg Tablets) | Experimental | Not described Receives: Drug: Rabeprazole sodium, 40 mg Tablets (two 20 mg Tablets) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Duration With An Intragastric pH >= 4 During The Entire 24 Hours Of Day 5 Administration
The 24-hour intragastric pH monitoring was performed on Day 5 of administration in each study period (Period I-IV). Data was displayed based on the participant's CYP2C19 genotype: CYP2C19-EM are extensive metabolizers who have normal metabolizing capacity. CYP2C19-PM are poor metabolizers with a metabolizing capacity deficiency or remarkably decreased metabolizing capacity.
Measured: Day 5 of administration during Period I-IV
Secondary outcomes (2)
Pharmacokinetic Parameter: Maximal Drug Concentration (Cmax)
Pharmacokinetic parameter: maximal drug concentration (Cmax) measured in nanograms per milliliter (ng/mL) was calculated on Day 1 and Day 5 of administration during each Period (I-IV).
Data was displayed based on the participant's CYP2C19 genotype: CYP2C19-EM are extensive metabolizers who have normal metabolizing capacity. CYP2C19-PM are poor metabolizers with a metabolizing capacity deficiency or remarkably decreased metabolizing capacity.
Measured: Day 1 and Day 5 of administration during Period I-IV
Pharmacokinetic Parameter: Area Under the Plasma Concentration-Time Curve From Time 0 to Time t (AUC[0-t])
Pharmacokinetic parameter: Area under the plasma concentration-time curve from time 0 (administration of the drug) to time t (the last quantifiable concentration time point). AUC measured in nanogram hours per milliliter (ng*h/mL) was calculated on Day 1 and Day 5 of administration during each Period (I-IV).
Data was displayed based on the participant's CYP2C19 genotype: CYP2C19-EM are extensive metabolizers who have normal metabolizing capacity. CYP2C19-PM are poor metabolizers with a metabolizing capacity deficiency or remarkably decreased metabolizing capacity.
Measured: Day 1 and Day 5 of administration during Period I-IV (0, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24 hours post-dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Masahiro Munesue, Study director, Japan/Asia Clinical Research Product Creation Unit, Japan Clinical Development, Japan Clinical Development Section
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01202071
- Sponsor's protocol ID
- E3810-J081-040
- Status last verified
- Nov 2012
- First submitted
- 14 Sep 2010
- Last updated
- 30 Nov 2012
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Hayato S, Hasegawa S, Hojo S, Okawa H, Abe H, Sugisaki N, Munesue M, Horai Y, Ohnishi A. Dose-response relationships of rabeprazole 5, 10, 20, and 40 mg once daily on suppression of gastric acid secretion through the night in healthy Japanese individuals with different CYP2C19 genotypes. Eur J Clin Pharmacol. 2012 May;68(5):579-88. doi: 10.1007/s00228-011-1164-7. Epub 2011 Nov 23.
PubMed 22108775
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Pharmacological Study of Rabeprazole Sodium in Japanese Healthy Adult Male Volunteers
- ClinicalTrials.gov ID
- NCT01202071
- Acronym / sponsor ID
- E3810-J081-040
- Conditions
- Healthy
- Keywords
- Rabeprazole, proton pump inhibitor, pharmacokinetics, pharmacodynamics, healthy adult male Japanese subjects
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 15 Sep 2010 (estimated)
- Results
- Posted 27 Nov 2012
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 compare the pharmacodynamics/pharmacokinetics of 5 mg, 10 mg, 20 mg and 40 mg of Rabeprazole sodium (E3810) when administered repeatedly once daily for 5 days to healthy adult male Japanese participants. This was a single-center, open-label, randomized, four-treatment, four-way crossover study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Rabeprazole sodium Tablets, 5 mg | Experimental | Drug: Rabeprazole sodium, 5 mg Tablets |
| Rabeprazole sodium Tablets, 10 mg | Experimental | Drug: Rabeprazole sodium, 10 mg Tablets |
| Rabeprazole sodium Tablets, 20 mg | Experimental | Drug: Rabeprazole sodium, 20 mg Tablets |
| Rabeprazole sodium Tablets, 40 mg (two 20 mg Tablets) | Experimental | Drug: Rabeprazole sodium, 40 mg Tablets (two 20 mg Tablets) |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy adult Japanese male between the age of 20-40
- body mass index between 18.5-25
Key exclusion criteria (4 listed)
- clinically significant abnormal physical examination, vital signs or electrocardiogram
- use of any prescription medication, antacid, nutritional supplement, vitamin preparation, or herb-containing drug within the previous 4 weeks
- use of any non-prescription medication within the previous 1 week
- history of drug or alcohol abuse
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 |
|---|---|---|
| Rabeprazole sodium, 5 mg TabletsAlso: E3810, E3810-J081-040Rabeprazole sodium Tablets, 5 mg administered for 5 days. Day 1 and Day 5: participants received a single dose with 200 mL of water in the morning while fasting for 10 hours or longer. Day 2 to Day 4: participants received a single dose with 200 mL of water >= 2 hours after the completion of breakfast. | Drug | Rabeprazole sodium Tablets, 5 mg |
| Rabeprazole sodium, 10 mg TabletsAlso: E3810, E3810-J081-040Rabeprazole sodium Tablets, 10 mg administered for 5 days. Day 1 and Day 5: participants received a single dose with 200 mL of water in the morning while fasting for 10 hours or longer. Day 2 to Day 4: participants received a single dose with 200 mL of water >= 2 hours after the completion of breakfast. | Drug | Rabeprazole sodium Tablets, 10 mg |
| Rabeprazole sodium, 20 mg TabletsAlso: E3810, E3810-J081-040Rabeprazole sodium Tablets, 20 mg administered for 5 days. Day 1 and Day 5: participants received a single dose with 200 mL of water in the morning while fasting for 10 hours or longer. Day 2 to Day 4: participants received a single dose with 200 mL of water >= 2 hours after the completion of breakfast. | Drug | Rabeprazole sodium Tablets, 20 mg |
| Rabeprazole sodium, 40 mg Tablets (two 20 mg Tablets)Also: E3810, E3810-J081-040Rabeprazole sodium Tablets, 40 mg (two 20 mg Tablets) administered for 5 days. Day 1 and Day 5: participants received a single dose with 200 mL of water in the morning while fasting for 10 hours or longer. Day 2 to Day 4: participants received a single dose with 200 mL of water, >=2 hours after the completion of breakfast. | Drug | Rabeprazole sodium Tablets, 40 mg (two 20 mg Tablets) |
Primary outcome
Percentage Duration With An Intragastric pH >= 4 During The Entire 24 Hours Of Day 5 Administration
Time frame: Day 5 of administration during Period I-IV
The 24-hour intragastric pH monitoring was performed on Day 5 of administration in each study period (Period I-IV). Data was displayed based on the participant's CYP2C19 genotype: CYP2C19-EM are extensive metabolizers who have normal metabolizing capacity. CYP2C19-PM are poor metabolizers with a metabolizing capacity deficiency or remarkably decreased metabolizing capacity.
2 secondary outcomes
Pharmacokinetic Parameter: Maximal Drug Concentration (Cmax)
Time frame: Day 1 and Day 5 of administration during Period I-IV
Pharmacokinetic Parameter: Area Under the Plasma Concentration-Time Curve From Time 0 to Time t (AUC[0-t])
Time frame: Day 1 and Day 5 of administration during Period I-IV (0, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24 hours post-dose)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22108775Hayato S, Hasegawa S, Hojo S, Okawa H, Abe H, Sugisaki N, Munesue M, Horai Y, Ohnishi A. Dose-response relationships of rabeprazole 5, 10, 20, and 40 mg once daily on suppression of gastric acid secretion through the night in healthy Japanese individuals with different CYP2C19 genotypes. Eur J Clin Pharmacol. 2012 May;68(5):579-88. doi: 10.1007/s00228-011-1164-7. Epub 2011 Nov 23.
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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.
Masahiro Munesue study director
Japan/Asia Clinical Research Product Creation Unit, Japan Clinical Development, Japan Clinical Development Section
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rabeprazole sodium, 5 mg Tablets, Rabeprazole sodium, 10 mg Tablets and Rabeprazole sodium, 20 mg Tablets in people with Healthy, run by Eisai Co., Ltd. at 1 site in Japan.
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 2 inclusion and 4 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 30 Nov 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 Japan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage Duration With An Intragastric pH >= 4 During The Entire 24 Hours Of Day 5 Administration (time frame: Day 5 of administration during Period I-IV). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01202071, which also lists 1 linked publication.
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 30 Nov 2012.