Pharmacodynamic Properties of CJ-12420 on Evening Dosing

February 3, 2017 updated by: HK inno.N Corporation

Phase I Study to Investigate Pharmacodynamics of CJ-12420 Compared to Dexlansoprazole With Evening Dosing

The purpose of this study is to compare and evaluate impact on pharmacodynamic characteristics of CJ-12420 and dexlansoprazole with evening dosing in healthy male volunteers

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

Evaluation Criteria:

  1. Pharmacokinetic Endpoints Cmax, tmax, AUClast of CJ-12420
  2. Pharmacodynamics Endpoints Time pH > 4 Time pH > 6 Integrated acidity Percent inhibition of integrated acidity Percent inhibition time gastric pH ≤ 4 Median pH
  3. Safety Assessments Physical examination, ECGs, vital signs (blood pressure, heart rate, body temperature), laboratory test (CBC, Chemistry, UA), and adverse events (AEs)

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.
24

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

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Healthy male volunteers aged ≥20 to ≤45 years
  2. Body mass Index (BMI) of 19 to 28kg/m2 ; and a total body weight ≥ 50kg

  3. Medically healthy without clinically significant vital signs (blood pressure in sitting position, heart rate)

    • 90 mmHg ≤ Systolic blood pressure (SBP) ≤ 140 mmHg
    • 50 mmHg ≤ Diastolic blood pressure (DBP) ≤ 95 mmHg
    • 45 (beats/min) ≤ Heart rate ≤ 95 (beats/min)
  4. Understand restriction during the study and voluntarily consent to participate in the study
  5. Consent to use the effective contraceptive methods (using abstinence, spermicide, and condom) and not to donate sperm during the study and until 30 days after completion of study
  6. Non-smoker or ex-smoker who stopped smoking for at least one year
  7. Negative H. pylori result in urea breath test (UBT)

Exclusion Criteria:

  1. History of clinically significant diseases in the digestive, kidney, liver, nervous, hemato-oncologic, endocrine, respiratory, immune, psychiatric, musculoskeletal, or cardiovascular system and other diseases that may harm safety of the subject or may affect the validity of study results, in the judgment of investigator
  2. History of allergy or hypersensitivity to any drugs including serious adverse events from treatments such as PPI (omeprazole, rabeprazole, lansoprazole) or P-CAB
  3. History surgery that may affect absorption, distribution, metabolism, and elimination of the study drug or in such a medical condition, at the discretion of the principal investigator or sub-investigator
  4. History of use of another investigational product within 90 days prior to screening visit
  5. Donation of a unit of whole blood within 60 days or blood components or transfusion within 30 days prior to screening visit
  6. Having special diet or changes in dietary habits within 30 days prior to screening visit
  7. Use of prescription drug within 14 days or over-the-count (OTC) drug including herbal medicine within 7 days prior to screening visit
  8. Alcohol > 21 units/week
  9. Caffeinated drink intake > 5units/day
  10. Positive on urinary drug screening test or urine nicotine test
  11. Positive human immunodeficiency virus (HIV), hepatitis B, hepatitis C, or syphilis test
  12. Clinically significant abnormal result of liver function (serum ALT, AST or total bilirubin levels ≥ 1.5 times the upper limit of normal (ULN))
  13. Inability to tolerate pH catheter insertion
  14. History of symptomatic GERD, erosive esophagitis (EE), duodenal ulcer, gastric ulcer, Barrett's esophagus, or Zollinger-Ellison Syndrome
  15. Any other conditions which would have made the subject unsuitable for the study in the opinion of the investigator

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
T1=CJ-12420 50mg QD evening (9PM)
Drug: CJ-12420 50mg
Other Names:
  • T1
Experimental: CJ-12420 100mg
T2=CJ-12420 100mg QD evening (9PM)
Drug: CJ-12420 100mg
Other Names:
  • T2
Experimental: CJ-12420 200mg
T3=CJ-12420 200mg QD evening (9PM)
Drug: CJ-12420 200mg
Other Names:
  • T3
Active Comparator: Dexlansopazole 60mg
R=dexlansoprazole 60mg QD evening (9p.m)
Drug: Dexlansoprazole 60 MG
Other Names:
  • R

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
Time pH > 4 of CJ-12420
Time Frame: 24 hours pH
intragastric pH
24 hours pH

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
Cmax of CJ-12420
Time Frame: up to 20 hours
maximum measured plasma concentraion
up to 20 hours
AUClast of CJ-12420
Time Frame: up to 20 hours
The area under the plasma concentration versus time curve from time 0 to the last measurable concentration
up to 20 hours
Cmax of dexlansoprazole
Time Frame: up to 20 hours
maximum measured plasma concentraion
up to 20 hours
AUClast of dexlansoprazole
Time Frame: up to 20 hours
The area under the plasma concentration versus time curve from time 0 to the last measurable concentration
up to 20 hours
Time pH > 4 of dexlansoprazole
Time Frame: 24 hours pH
intragastric pH
24 hours pH
Median pH > 4 of CJ-12420
Time Frame: 24 hours pH
intragastric pH
24 hours pH
Median pH > 4 of dexlansoprazole
Time Frame: 24 hours pH
intragastric pH
24 hours pH

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

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Eunji Kim, CJ HealthCare Corp.

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 (Actual)

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.
May 13, 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.
August 12, 2015

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.
August 12, 2015

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).
January 19, 2017

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.
February 3, 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.
February 6, 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.
February 6, 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.
February 3, 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.
February 1, 2017

More Information

Terms related to this study

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.
  • CJ_APA_105

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings