HealthyPhase 1NCT02509923
To Evaluate Pharmacokinetics and Pharmacodynamics of Z-215 in Healthy Male Subjects
A Phase 1 study testing Z-215 10mg, Z-215 20mg and Rabeprazole Sodium 10mg in people with Healthy, run by Zeria Pharmaceutical at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate pharmacokinetics and pharmacodynamics of Z-215 (10 mg, 20 mg, 40 mg) , compared with Rabeprazole Sodium (10 mg, 20 mg ) in Healthy Male Subjects. And to evaluate food-effect in Healthy Male Subjects administrated Z-215 20 mg. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Z-215 10mg, Z-215 20mg and Rabeprazole Sodium 10mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteJapan
- Study dates
- Jul 2015to Sep 2016
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Has negative results for H. pylori IgG antibody at screening.
- A body mass index 18.5≦BMI<25.0 kg/m^2 at screening.
- Able to understand the consent of the study and comply with the study. Able to give informed consent in writing before participating in the study.
Who cannot join
- Has a history of PPI allergy.
- Has a history of drug or food serious allergy.
- Presently has or has a history of diseases that may affect evaluation of the study results such as gastrointestinal, hepatic, renal, respiratory, endocrine, blood, cardiovascular, mental or congenial metabolic disease.
- Has a history of surgery (such as resection of the liver, kidney, or digestive tract) that may affect the pharmacokinetics of the study drug.
- History of previous and current acid-related diseases.
- Received H. pylori eradication treatment within 6 months before screening.
Show all 12Show fewer
- Has 450msec<QTC by Fridericia test at screening ECG .
- Has hypoacidity or anacidity. Or be determined that low gastric acid or no stomach acid by the gastric pH monitoring at baseline period.
- History or suspicion of drug, opioid, alcohol abuse or positive screening results.
- Use of any prescription drugs within 4 weeks prior to baseline period.
- Use of any over-the-counter drugs within 2 weeks prior to baseline period.
- Received blood transfusions within 12 weeks or donated ≥400mL of whole blood within 12 weeks or ≥200mL of whole blood within 4 weeks prior to baseline period. Donated platelet or plasma within 2 weeks prior to baseline period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Crossover, Pharmacokinetic and Pharmacodynamic Study of Z-215 Compared With Rabeprazole Sodium in Healthy Male Subjects
The purpose of this study is to evaluate pharmacokinetics and pharmacodynamics of Z-215 (10 mg, 20 mg, 40 mg) , compared with Rabeprazole Sodium (10 mg, 20 mg ) in Healthy Male Subjects. And to evaluate food-effect in Healthy Male Subjects administrated Z-215 20 mg.
- Conditions
- Healthy
- Being tested
- Z-215 10mg, Z-215 20mg, Rabeprazole Sodium 10mg, Rabeprazole Sodium 20mg
- Keywords
- Male Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Z-215 10mgDrug
Z-215 10mg, capsules
Z-215 20mgDrug
Z-215 20mg, capsules
Rabeprazole Sodium 10mgDrug
Rabeprazole Sodium 10mg tablets
Rabeprazole Sodium 20mgDrug
Rabeprazole Sodium 20mg tablets
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 3-way cross-over, Z-215 10 mg/day / Z-215 20 mg/day / Rabeprazole Sodium 10 mg/day Receives: Drug: Z-215 10mg; Drug: Z-215 20mg; Drug: Rabeprazole Sodium 10mg |
| 2 | Experimental | 3-way cross-over, Z-215 20 mg/day / Z-215 40 mg/day / Rabeprazole Sodium 20 mg/day Receives: Drug: Z-215 20mg; Drug: Rabeprazole Sodium 20mg |
| 3 | Experimental | 3-way cross-over, Z-215 20 mg/day (before breakfast) / Z-215 20 mg/day (after breakfast) / Rabeprazole Sodium 10 mg/day (after breakfast) Receives: Drug: Z-215 20mg; Drug: Rabeprazole Sodium 10mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-Hour Intragastric pH Profile
Summary statistics of the measurements on Day1 and Day5 of administration are to be calculated by dose.
Measured: 4 weeks
Cmax: Maximum Plasma Concentration for Z-215
Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose.
Measured: 4 weeks
tmax: Time to Reach Maximum Plasma Concentration (Cmax) for Z-215
Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose.
Measured: 4 weeks
t1/2: Terminal Elimination Half-life (t1/2) for Z-215
Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose.
Measured: 4 weeks
Lambda Z: Terminal Elimination Rate Constant (Lambda Z) for Z-215
Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose.
Measured: 4 weeks
AUC0-t: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Z-215
Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose.
Measured: 4 weeks
AUC0-24: Area Under the Plasma Concentration-Time Curve From Time 0 to 24 hour for Z-215
Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose.
Measured: 4 weeks
AUC0-∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Z-215
Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose.
Measured: 4 weeks
CL/F: Apparent Total Body Clearance (CL/F) Pharmacokinetic Parameter for Z-215
Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose.
Measured: 4 weeks
Vd/F: Apparent Volume of Distribution (Vd/F) Pharmacokinetic Parameter for Z-215
Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose.
Measured: 4 weeks
MRT0-∞: Mean Residence Time from Time 0 to Infinity for Z-215
Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose.
Measured: 4 weeks
Rac(Cmax): Accumulation Index of Cmax (Rac(Cmax)) for Z-215
Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose.
Measured: 4 weeks
Rac(AUC): Accumulation Index of AUC (Rac(AUC)) for Z-215
Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose.
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 posted28 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionMar 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeria Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02509923
- Sponsor's protocol ID
- Z215-02
- Status last verified
- Sep 2016
- First submitted
- 21 Jul 2015
- Last updated
- 22 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Crossover, Pharmacokinetic and Pharmacodynamic Study of Z-215 Compared With Rabeprazole Sodium in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02509923
- Acronym / sponsor ID
- Z215-02
- Conditions
- Healthy
- Keywords
- Male Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Zeria PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 28 Jul 2015 (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 evaluate pharmacokinetics and pharmacodynamics of Z-215 (10 mg, 20 mg, 40 mg) , compared with Rabeprazole Sodium (10 mg, 20 mg ) in Healthy Male Subjects. And to evaluate food-effect in Healthy Male Subjects administrated Z-215 20 mg.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Z-215 10mg, Drug: Z-215 20mg, Drug: Rabeprazole Sodium 10mg3-way cross-over, Z-215 10 mg/day / Z-215 20 mg/day / Rabeprazole Sodium 10 mg/day |
| 2 | Experimental | Drug: Z-215 20mg, Drug: Rabeprazole Sodium 20mg3-way cross-over, Z-215 20 mg/day / Z-215 40 mg/day / Rabeprazole Sodium 20 mg/day |
| 3 | Experimental | Drug: Z-215 20mg, Drug: Rabeprazole Sodium 10mg3-way cross-over, Z-215 20 mg/day (before breakfast) / Z-215 20 mg/day (after breakfast) / Rabeprazole Sodium 10 mg/day (after breakfast) |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Has negative results for H. pylori IgG antibody at screening.
- A body mass index 18.5≦BMI<25.0 kg/m^2 at screening.
- Able to understand the consent of the study and comply with the study. Able to give informed consent in writing before participating in the study.
Key exclusion criteria (12 listed)
- Has a history of PPI allergy.
- Has a history of drug or food serious allergy.
- Presently has or has a history of diseases that may affect evaluation of the study results such as gastrointestinal, hepatic, renal, respiratory, endocrine, blood, cardiovascular, mental or congenial metabolic disease.
- Has a history of surgery (such as resection of the liver, kidney, or digestive tract) that may affect the pharmacokinetics of the study drug.
- History of previous and current acid-related diseases.
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 |
|---|---|---|
| Z-215 10mgZ-215 10mg, capsules | Drug | 1 |
| Z-215 20mgZ-215 20mg, capsules | Drug | 1, 2, 3 |
| Rabeprazole Sodium 10mgRabeprazole Sodium 10mg tablets | Drug | 1, 3 |
| Rabeprazole Sodium 20mgRabeprazole Sodium 20mg tablets | Drug | 2 |
Primary outcome
24-Hour Intragastric pH Profile
Time frame: 4 weeks
Summary statistics of the measurements on Day1 and Day5 of administration are to be calculated by dose.
Cmax: Maximum Plasma Concentration for Z-215
Time frame: 4 weeks
Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose.
tmax: Time to Reach Maximum Plasma Concentration (Cmax) for Z-215
Time frame: 4 weeks
Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose.
t1/2: Terminal Elimination Half-life (t1/2) for Z-215
Time frame: 4 weeks
Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose.
Lambda Z: Terminal Elimination Rate Constant (Lambda Z) for Z-215
Time frame: 4 weeks
Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose.
AUC0-t: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Z-215
Time frame: 4 weeks
Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose.
AUC0-24: Area Under the Plasma Concentration-Time Curve From Time 0 to 24 hour for Z-215
Time frame: 4 weeks
Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose.
AUC0-∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Z-215
Time frame: 4 weeks
Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose.
CL/F: Apparent Total Body Clearance (CL/F) Pharmacokinetic Parameter for Z-215
Time frame: 4 weeks
Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose.
Vd/F: Apparent Volume of Distribution (Vd/F) Pharmacokinetic Parameter for Z-215
Time frame: 4 weeks
Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose.
MRT0-∞: Mean Residence Time from Time 0 to Infinity for Z-215
Time frame: 4 weeks
Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose.
Rac(Cmax): Accumulation Index of Cmax (Rac(Cmax)) for Z-215
Time frame: 4 weeks
Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose.
Rac(AUC): Accumulation Index of AUC (Rac(AUC)) for Z-215
Time frame: 4 weeks
Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose.
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 22 Sep 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Z-215 10mg, Z-215 20mg and Rabeprazole Sodium 10mg in people with Healthy, run by Zeria Pharmaceutical 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 3 inclusion and 12 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 22 Sep 2016. 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 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?
24-Hour Intragastric pH Profile (time frame: 4 weeks). The study lists 13 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 22 Sep 2016.