To Investigate Pharmacokinetics and Pharmacodynamics of CJ-12420 After Single and Multiple Dose Administration

January 19, 2017 updated by: HK inno.N Corporation

A Phase I , Study to Investigate Pharmacokinetics and Pharmacodynamics of Single and Multiple Dose of CJ-12420 50mg, 100mg in Helicobacter Pylori ?

The purpose of this study is to compare the pharmacokinetics and pharmacodynamics of CJ-12420 after single and multiple dose administration according to H. pylori infection.

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.

Detailed Description

  1. Cohort 1: To investigate the pharmacokinetics and pharmacodynamics of CJ-12420 after the multiple dose administration in H. pylori negative volunteers.
  2. Cohort 2: To investigate the pharmacokinetics and pharmacodynamics of CJ-12420 after the single dose administration in H. pylori positive volunteers.

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.
16

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

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:

  • Healthy male volunteers between 20 to 45 years of age (inclusive)
  • Body mass index (BMI) in the range of 19~28 kg/㎡ and weighted at least 50kg

  • Medically healthy with no clinically significant vital signs (blood pressure in the sitting position, pulse rate)

    • 90 mmHg ≤ systolic blood pressure ≤ 140 mmHg
    • 50 mmHg ≤ diastolic blood pressure ≤ 95 mmHg
    • 45 beats per minute ≤ pulse rate ≤ 95 beats per minute
  • Understood the requirements of the study and voluntarily consented to participate in the study
  • Agreed to be sexually abstinent or to use a condom or spermicide when engaging in sexual activity and not to donate sperm during the course of the study for 30 days following completion of the study
  • Non-smokers or non-users of nicotine-containing products for at least 1 year
  • [Cohort 1] H. pylori negative as determined by urea breath test and serum IgG antibody
  • [Cohort 2] H. pylori positive as determined by urea breath test and serum IgG

Exclusion Criteria:

  • History of clinically significant gastrointestinal, renal, hepatic, neurologic, hemato-oncologic, endocrine, pulmonary, immunologic, psychiatric, musculoskeletal, or cardiovascular disease or any other condition, which in the opinion of the investigators, would jeopardize the safety of the subject or impact the validity of the study results
  • History of allergy or hypersensitivity to any drug, including prior serious adverse reaction to PPIs or P-CABs
  • Undergone surgery or in a medical condition, which in the judgment of the PI or investigators may affect absorption, distribution, metabolism or elimination of the study drug
  • Administered other drug(s) in other clinical study within 60 days prior to screening visit
  • Donated blood within 60 days or blood components within 30 days, or had been transfused plasma within 30 days prior to screening visit
  • On special diet or have experienced substantial changes in eating habits within 30 days prior to screening visit
  • Used any prescription medication within 14 days, or any other OTC medications including herbal products within 7 days prior to screening visit
  • Consumed over 21 units/week of alcohol
  • Consumed over 5 units/day of caffeine-containing beverage
  • Positive urine screen for drugs and/or cotinine
  • Positive blood screen for human immunodeficiency virus (HIV), hepatitis B or C, or syphilis
  • Clinically significant abnormalities of liver function tests (≥1.5 fold of normal upper limit in the level of L-alanine aminotransferase (ALT), L-aspartate aminotransferase (AST) or total bilirubin)
  • Unable to bear pH meter catheter insertion
  • History of symptomatic GERD, erosive esophagitis, duodenal ulcer, gastric ulcer, Barrett's esophagus, or Zollinger-Ellison syndrome
  • Clinically significant observations considered as unsuitable based on medical judgment by investigators

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: Parallel 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: CJ-12420 50mg(HP-)
CJ-12420 50mg in H. pylori negative subject
Drug: CJ-12420 50mg(HP-)
CJ-12420 50mg in H. pylori negative subject
Other Names:
  • not yet determined
Experimental: CJ-12420 100mg(HP-)
CJ-12420 100mg in H. pylori negative subject
Drug: CJ-12420 100mg(HP-)
CJ-12420 100mg in H. pylori negative subject
Other Names:
  • not yet determined
Experimental: CJ-12420 50mg(HP+)
CJ-12420 50mg in H. pylori positive subject
Drug: CJ-12420 50mg(HP+)
CJ-12420 50mg in H. pylori positive subject
Other Names:
  • not yet determined
Experimental: CJ-12420 100mg(HP+)
CJ-12420 100mg in H. pylori positive subject
Drug: CJ-12420 100mg(HP+)
CJ-12420 100mg in H. pylori positive subject
Other Names:
  • not yet determined

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
Time Frame
Peak Plasma Concentration (Cmax) of CJ-12420
Time Frame: up to 12 hours
up to 12 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Area under the plasma concentration versus time curve (AUC) of CJ-12420
Time Frame: up to 12 hours
up to 12 hours
Time of maximum observed concentration(tmax) of CJ-12420
Time Frame: up to 12 hours
up to 12 hours
Half life(t1/2β) of CJ-12420
Time Frame: up to 12 hours
up to 12 hours
Mean pH
Time Frame: Day -1, Day 1, Day 7 up to 24 hours
Data from the pH probe monitoring
Day -1, Day 1, Day 7 up to 24 hours
Time at pH > 4(%)
Time Frame: Day -1, Day 1, Day 7 up to 24 hours
the percent of time the pH as data from the pH probe monitoring
Day -1, Day 1, Day 7 up to 24 hours
Time at pH > 6(%)
Time Frame: Day -1, Day 1, Day 7 up to 24 hours
the percent of time the pH as data from the pH probe monitoring
Day -1, Day 1, Day 7 up to 24 hours

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.
HK inno.N Corporation

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Asan Medical Center

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.
January 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.
April 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.
April 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).
December 28, 2016

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.
January 1, 2017

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.
January 4, 2017

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.
January 20, 2017

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.
January 19, 2017

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.
January 1, 2017

More Information

Terms related to this study

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.
  • [CJ_APA_104]

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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