Safety, Tolerability, PK, PD of Escalating Single and Multiple Oral Doses of CJ-12420 in Healthy Male Subjects

Study Overview
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Brief Summary
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The objectives of this study are: To evaluate the safety and tolerability of single and multiple oral doses of CJ-12420 in healthy male subjects. To evaluate the single- and multiple-dose PK of orally administered CJ-12420 in healthy male subjects. To evaluate the single- and multiple-dose PD of orally administered CJ-12420 in healthy male subjects. To compare the multiple-dose pharmacodynamics (PD) of orally administered CJ-12420 and esomeprazole in healthy male subjects.

Official Title
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A Phase I, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study, to Investigate the Safety, Tolerability, PK and PD of Escalating Single and Multiple Oral Doses of CJ-12420 in Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: CJ-12420
* Drug: Esomeprazole 40mg


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 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) Non-smokers or non-users of nicotine-containing products for at least 3 months Exclusion Criteria: 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

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CJ-12420 50mg<br>Single dose 8 volunteers will be administered CJ-12420 50mg or placebo comparators.(CJ-12420:placebo=6:2) | Drug: CJ-12420<br> <br> |
| Experimental: CJ-12420 100mg<br>Single dose 8 volunteers will be administered CJ-12420 100mg or placebo comparators.(CJ-12420:placebo=6:2) | Drug: CJ-12420<br> <br> |
| Experimental: CJ-12420 200mg<br>Single dose 8 volunteers will be administered CJ-12420 200mg or placebo comparators.(CJ-12420:placebo=6:2) | Drug: CJ-12420<br> <br> |
| Experimental: CJ-12420 400mg<br>Single dose 8 volunteers will be administered CJ-12420 400mg or placebo comparators.(CJ-12420:placebo=6:2) | Drug: CJ-12420<br> <br> |
| Experimental: CJ-12420 100mg (repeated dose)<br>Repeat doses 100mg is the anticipated dose 8 volunteers will be administered CJ-12420 100mg or placebo comparator.(CJ-12420:placebo=6:2) | Drug: CJ-12420<br> <br> |
| Experimental: CJ-12420 200mg (repeated dose)<br>Repeat doses 200mg is the anticipated dose 8 volunteers will be administered CJ-12420 200mg or placebo comparator.(CJ-12420:placebo=6:2) | Drug: CJ-12420<br> <br> |
| Active Comparator: Esomeprazole 40mg<br>8 volunteers will be administered Esomeprazole 40mg | Drug: Esomeprazole 40mg<br> <br> * Other names: Nexium;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the PK, PD, safety and tolerability of escalating single and multiple oral doses of CJ-12420 in healthy male subjects |  | Throughout the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety, Tolerability, Pharmacokinetics, Pharmacodynamics