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

• Area under the plasma concentration versus time curve (AUC) of CJ-12406 [ Time Frame: 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose ] [ Designated as safety issue: No ]
  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.
• Number of participants with adverse events [ Time Frame: A range of 17 days - from screening to gollow-up visit ] [ Designated as safety issue: Yes ]
• Peak plasma concentration (Cmax) of CJ-12406 [ Time Frame: 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose ] [ Designated as safety issue: No ]
  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.
• Area under the plasma concentration versus time curve (AUC) of active metabolite [ Time Frame: 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose ] [ Designated as safety issue: No ]
  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.
• Peak plasma concentration (Cmax) of active metabolite [ Time Frame: 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose ] [ Designated as safety issue: No ]
  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.

• AUCt of CJ-12406 [ Time Frame: 10 days ] [ Designated as safety issue: No ]
  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.
• Number of participants with adverse events [ Time Frame: A range of 17 days - from screening to gollow-up visit ] [ Designated as safety issue: Yes ]
• Cmax of CJ-12406 [ Time Frame: 10 days ] [ Designated as safety issue: No ]
  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.
• AUC of active metabolite [ Time Frame: 10 days ] [ Designated as safety issue: No ]
  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.
• Cmax of active metabolite [ Time Frame: 10 days ] [ Designated as safety issue: No ]
  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.

• H. pylori eradication rate [ Time Frame: 38 days post dose (plus of minus 1 day) ] [ Designated as safety issue: No ]
  UBT test
• The percent time of intragastric pH>4 [ Time Frame: 7 days post dose ] [ Designated as safety issue: No ]

• H. pylori eradication rate [ Time Frame: 38 days (plus of minus 1 day) ] [ Designated as safety issue: No ]
  UBT test
• The percent time of intragastric pH>4 [ Time Frame: 7 days ] [ Designated as safety issue: No ]

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.

• Drug: Placebo
  single and multiple dose
• Drug: CJ-12406
  single and multiple dose

• Placebo Comparator: Placebo
  Intervention: Drug: Placebo
• Experimental: CJ-12406
  CJ-12406 Tablet, daily for 1 day or bid for 10 days
  Intervention: Drug: CJ-12406

Inclusion Criteria:

1. Male volunteers in the age between 20 and 45 years old
2. Subjects with no history of any significant chronic disease
3. The weight range is not exceed ±20% of ideal weight. Ideal weight = [height -100]*0.9
4. Judged to be in good health on the basis of their vital sign, ECG, physical exam and routine laboratory data
5. Available for the entire study period
6. Willing to adhere to protocol requirements and sign a informed consent form
7. Multiple escalation study; H. pylori positive, as determined by the urea breath test

Exclusion Criteria:

1. History of clinically significant allergies including drug allergies
2. History of clinically significant hepatic, renal, gastrointestinal, pulmonary, ,musculoskeletal, endocrine, psychiatric, hematologic, oncologic, neurologic or cardiovascular disease
3. Symptom of an acute illness within 4 weeks prior to drug administration
4. History of surgery except or gastrointestinal diseases which might significantly change absorption of medicines
5. Treatments or symptoms of symptomatic GERD, gastric ulcer, duodenal ulcer, functional dyspepsia, irritable bowel syndrome within 3 months prior to drug administration

6. 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

7. Clinically significant vital signs

   • Hypotension (SBP ≤ 89 mmHg)
   • Hypertension (SBP ≥ 141 mmHg or DBP ≥ 91 mmHg)
   • Tachycardia (≥ 101 beats/min)
8. History of drug and alcohol abuse(alcohol > 30 g/day)
9. Subjects who have ever smoke within 3 months prior to drug administration
10. Positive urine screen for drugs and cotinine
11. Use of any other medication, including herbal products, within the 2 weeks before dosing
12. 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
13. Donated blood within 60 days prior to dosing
14. Participated in a previous clinical trial within 90 days prior to dosing
15. Subjects considered as unsuitable based on medical judgement by investigators