Status:
COMPLETED
Phase I Study to Investigate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of CJ-12406 in Healthy Male Subjects
Lead Sponsor:
HK inno.N Corporation
Conditions:
Digestive System Diseases
Eligibility:
MALE
20-45 years
Phase:
PHASE1
Brief Summary
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 afte...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT01489774
Start Date
May 1 2011
End Date
June 1 2012
Last Update
August 2 2012
Active Locations (1)
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1
Inje University Busan Paik Hospital
Busan, South Korea, 614-735