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

Study Overview
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Brief Summary
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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.

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

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: CJ-12420 50mg(HP-)
* Drug: CJ-12420 100mg(HP-)
* Drug: CJ-12420 50mg(HP+)
* Drug: CJ-12420 100mg(HP+)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CJ-12420 50mg(HP-)<br>CJ-12420 50mg in H. pylori negative subject | Drug: CJ-12420 50mg(HP-)<br>* CJ-12420 50mg in H. pylori negative subject<br>* Other names: not yet determined;|
| Experimental: CJ-12420 100mg(HP-)<br>CJ-12420 100mg in H. pylori negative subject | Drug: CJ-12420 100mg(HP-)<br>* CJ-12420 100mg in H. pylori negative subject<br>* Other names: not yet determined;|
| Experimental: CJ-12420 50mg(HP+)<br>CJ-12420 50mg in H. pylori positive subject | Drug: CJ-12420 50mg(HP+)<br>* CJ-12420 50mg in H. pylori positive subject<br>* Other names: not yet determined;|
| Experimental: CJ-12420 100mg(HP+)<br>CJ-12420 100mg in H. pylori positive subject | Drug: CJ-12420 100mg(HP+)<br>* CJ-12420 100mg in H. pylori positive subject<br>* Other names: not yet determined;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Plasma Concentration (Cmax) of CJ-12420 |  | up to 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration versus time curve (AUC) of CJ-12420 |  | up to 12 hours | 
| Time of maximum observed concentration(tmax) of CJ-12420 |  | up to 12 hours | 
| Half life(t1/2β) of CJ-12420 |  | up to 12 hours | 
| Mean pH | Data from the pH probe monitoring | Day -1, Day 1, Day 7 up to 24 hours | 
| Time at pH > 4(%) | 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(%) | the percent of time the pH as data from the pH probe monitoring | Day -1, Day 1, Day 7 up to 24 hours |