Phase I Study to Investigate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of CJ-12406 in Healthy Male Subjects

Study Overview
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Brief Summary
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Study objectives To evaluate the safety, tolerability, and pharmacokinetics of escalating single oral doses of CJ-12406 in healthy male subjects. To evaluate the pharmacodynamics of CJ-12406 after multiple oral administrations to healthy male subjects. To evaluate the effect of food on the pharmacokinetic of a single oral dose of CJ-12406 in healthy male subjects.

Official Title
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A Dose Block-randomized, Double-blind, Placebo-controlled, Single/Multiple Dose, Dose-escalation Clinical Study to Investigate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of CJ-12406 After Oral Administration in Healthy Male Subjects, Phase I Study

Conditions
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Digestive System Diseases

Intervention / Treatment
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* Drug: Placebo
* Drug: CJ-12406


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 Subjects with no history of any significant chronic disease The weight range is not exceed ±20% of ideal weight. Ideal weight = [height -100]*0.9 Judged to be in good health on the basis of their vital sign, ECG, physical exam and routine laboratory data Available for the entire study period Willing to adhere to protocol requirements and sign a informed consent form Multiple escalation study; H. pylori positive, as determined by the urea breath test Exclusion Criteria: History of clinically significant allergies including drug allergies History of clinically significant hepatic, renal, gastrointestinal, pulmonary, ,musculoskeletal, endocrine, psychiatric, hematologic, oncologic, neurologic or cardiovascular disease Symptom of an acute illness within 4 weeks prior to drug administration History of surgery except or gastrointestinal diseases which might significantly change absorption of medicines Treatments or symptoms of symptomatic GERD, gastric ulcer, duodenal ulcer, functional dyspepsia, irritable bowel syndrome within 3 months prior to drug administration Clinical laboratory test values are outside the accepted normal range AST or ALT >1.25 times to normal range Creatinine clearance <80 mL/min 12-lead ECG; PR ≥ 210 msec, QRS ≥ 120 msec, QT ≥ 500 msec, QTcF ≥ 450 msec Clinically significant vital signs Hypotension (SBP ≤ 89 mmHg) Hypertension (SBP ≥ 141 mmHg or DBP ≥ 91 mmHg) Tachycardia (≥ 101 beats/min) History of drug and alcohol abuse(alcohol > 30 g/day) Subjects who have ever smoke within 3 months prior to drug administration Positive urine screen for drugs and cotinine Use of any other medication, including herbal products, within the 2 weeks before dosing Special diet known to interfere with the absorption, distribution, metabolism or excretion of drugs (especially, consumption of grapefruit juice) within 7 days prior to drug administration Donated blood within 60 days prior to dosing Participated in a previous clinical trial within 90 days prior to dosing Subjects considered as unsuitable based on medical judgement 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* single and multiple dose<br>|
| Experimental: CJ-12406<br>CJ-12406 Tablet, daily for 1 day or bid for 10 days | Drug: CJ-12406<br>* single and multiple dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration versus time curve (AUC) of CJ-12406 | Blood samples were collected before dosing and 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose (multiple dose study; 1 and 10 day). For multiple dose study, additional blood samples will be drawn predose (immediately prior to morning dosing) on days 3, 7, and 9. | 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose | 
| Number of participants with adverse events |  | A range of 17 days - from screening to gollow-up visit | 
| Peak plasma concentration (Cmax) of CJ-12406 | Blood samples were collected before dosing and 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose (multiple dose study; 1 and 10 day). For multiple dose study, additional blood samples will be drawn predose (immediately prior to morning dosing) on days 3, 7, and 9. | 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose | 
| Area under the plasma concentration versus time curve (AUC) of active metabolite | Blood samples were collected before dosing and 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose (multiple dose study; 1 and 10 day). For multiple dose study, additional blood samples will be drawn predose (immediately prior to morning dosing) on days 3, 7, and 9. | 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose | 
| Peak plasma concentration (Cmax) of active metabolite | Blood samples were collected before dosing and 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose (multiple dose study; 1 and 10 day). For multiple dose study, additional blood samples will be drawn predose (immediately prior to morning dosing) on days 3, 7, and 9. | 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| H. pylori eradication rate | UBT test | 38 days post dose (plus of minus 1 day) | 
| The percent time of intragastric pH>4 |  | 7 days post dose |