Pharmacodynamic Properties of CJ-12420 on Evening Dosing

Study Overview
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Brief Summary
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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

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

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Dexlansoprazole 60 MG
* Drug: CJ-12420 50mg
* Drug: CJ-12420 100mg
* Drug: CJ-12420 200mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male volunteers aged ≥20 to ≤45 years Body mass Index (BMI) of 19 to 28kg/m2 ; and a total body weight ≥ 50kg 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) Understand restriction during the study and voluntarily consent to participate in the study 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 Non-smoker or ex-smoker who stopped smoking for at least one year Negative H. pylori result in urea breath test (UBT) Exclusion Criteria: 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 History of allergy or hypersensitivity to any drugs including serious adverse events from treatments such as PPI (omeprazole, rabeprazole, lansoprazole) or P-CAB 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 History of use of another investigational product within 90 days prior to screening visit Donation of a unit of whole blood within 60 days or blood components or transfusion within 30 days prior to screening visit Having special diet or changes in dietary habits within 30 days prior to screening visit Use of prescription drug within 14 days or over-the-count (OTC) drug including herbal medicine within 7 days prior to screening visit Alcohol > 21 units/week Caffeinated drink intake > 5units/day Positive on urinary drug screening test or urine nicotine test Positive human immunodeficiency virus (HIV), hepatitis B, hepatitis C, or syphilis test Clinically significant abnormal result of liver function (serum ALT, AST or total bilirubin levels ≥ 1.5 times the upper limit of normal (ULN)) Inability to tolerate pH catheter insertion History of symptomatic GERD, erosive esophagitis (EE), duodenal ulcer, gastric ulcer, Barrett's esophagus, or Zollinger-Ellison Syndrome Any other conditions which would have made the subject unsuitable for the study in the opinion of the investigator

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<br>T1=CJ-12420 50mg QD evening (9PM) | Drug: CJ-12420 50mg<br> <br> * Other names: T1;|
| Experimental: CJ-12420 100mg<br>T2=CJ-12420 100mg QD evening (9PM) | Drug: CJ-12420 100mg<br> <br> * Other names: T2;|
| Experimental: CJ-12420 200mg<br>T3=CJ-12420 200mg QD evening (9PM) | Drug: CJ-12420 200mg<br> <br> * Other names: T3;|
| Active Comparator: Dexlansopazole 60mg<br>R=dexlansoprazole 60mg QD evening (9p.m) | Drug: Dexlansoprazole 60 MG<br> <br> * Other names: R;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time pH > 4 of CJ-12420 | intragastric pH | 24 hours pH | 

Secondary Outcome Measures

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