Food-Effect on PK and PD of Single Oral Dose of CJ-12420 in Healthy Male Subjects

Study Overview
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Brief Summary
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Primary: To evaluate food effect on the pharmacokinetics (PK) of a single oral dose of CJ-12420 in healthy male subjects. Secondary To explore food effect on the pharmacodynamics (PD) of single oral dose of CJ-12420 in healthy male subjects(PD/PK group) To evaluate the safety of single oral dose of CJ-12420 in healthy male subjects under fed or fasting condition.

Official Title
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Clinical Study to Evaluate Food-Effect on Pharmacokinetics and Pharmacodynamics of Single Oral Dose of CJ-12420 in Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: CJ-12420 200mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male volunteers in the age between 20 and 45 years old(inclusive) Body mass index (BMI) in the range of 19 to 28 kg/m2 and weighing at least 50 kg (inclusive) Medically healthy with no clinically significant vital signs (sitting position blood pressure, 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 Understand the requirements of the study and voluntarily consent to participate in the study Exclusion Criteria: Subjects will be excluded from the study if there is evidence of any of the following criteria: Last three criteria will be applied ONLY to PD/PK group. History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary,immunologic, psychiatric, musculoskeletal or cardiovascular disease or any other condition, which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results History of allergy or sensitivity to any drug, including any prior serious adverse reaction to PPIs (e.g. omeprazole, rabeprazole, lansoprazole) History of symptomatic GERD, erosive esophagitis, duodenal ulcer, gastric ulcer, Barrett's esophagus or Zollinger-Ellison syndrome, previous positive H. pylori The following criteria will be applied ONLY to PD/PK group H.pylori positive, as determined by the urea breath test Urine cotinine test positive Subject who were unable to be applicable for pH meter catheter

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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence 1<br>Drug: CJ-12420 200mg Period1: CJ-12420 under fed condition Period2: CJ-12420 under fasting condition | Drug: CJ-12420 200mg<br>* Period1: CJ-12420 200mg fed condition Period2: CJ-12420 200mg fasting condition Period1: CJ-12420 200mg fasting condition Period2: CJ-12420 200mg fed condition<br>* Other names: CJ-12420;|
| Experimental: Sequence 2<br>Drug: CJ-12420 200mg Period1: CJ-12420 under fasting condition Period2: CJ-12420 under fed condition | Drug: CJ-12420 200mg<br>* Period1: CJ-12420 200mg fed condition Period2: CJ-12420 200mg fasting condition Period1: CJ-12420 200mg fasting condition Period2: CJ-12420 200mg fed condition<br>* Other names: CJ-12420;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric mean ratio and 90% CI for log-transformed AUClast |  | Blood sampling during 24 or 48 hrs after administration | 
| Geometric mean ratio and 90% CI for log-transformed Cmax |  | Blood sampling during 24 or 48 hrs after administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time pH > 4 |  | 24 hour before and after IP administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Food-Effect, Pharmacokinetics, Pharmacodynamics