To Evaluate Pharmacokinetics and Pharmacodynamics of Z-215 in Healthy Male Subjects

September 21, 2016 updated by: Zeria Pharmaceutical

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 1
3-way cross-over, Z-215 10 mg/day / Z-215 20 mg/day / Rabeprazole Sodium 10 mg/day
Drug: Z-215 10mg
Z-215 10mg, capsules
Drug: Z-215 20mg
Z-215 20mg, capsules
Drug: Rabeprazole Sodium 10mg
Rabeprazole Sodium 10mg tablets
Experimental: 2
3-way cross-over, Z-215 20 mg/day / Z-215 40 mg/day / Rabeprazole Sodium 20 mg/day
Drug: Z-215 20mg
Z-215 20mg, capsules
Drug: Rabeprazole Sodium 20mg
Rabeprazole Sodium 20mg tablets
Experimental: 3
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)
Drug: Z-215 20mg
Z-215 20mg, capsules
Drug: Rabeprazole Sodium 10mg
Rabeprazole Sodium 10mg tablets

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
4 weeks
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.
4 weeks
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.
4 weeks
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.
4 weeks
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.
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
Time Frame: 4 weeks
Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose.
4 weeks
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.
4 weeks
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.
4 weeks
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.
4 weeks
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.
4 weeks
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.
4 weeks
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.
4 weeks
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.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zeria Pharmaceutical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 21, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 22, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Z215-02

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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