Status:
COMPLETED
Safety, Tolerability, PK, PD of Escalating Single and Multiple Oral Doses of CJ-12420 in Healthy Male Subjects
Lead Sponsor:
HK inno.N Corporation
Conditions:
Healthy
Eligibility:
MALE
20-45 years
Phase:
PHASE1
Brief Summary
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 o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT01473173
Start Date
November 1 2011
End Date
August 1 2012
Last Update
April 10 2013
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea