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

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