To Investigate Pharmacokinetics and Pharmacodynamics of CJ-12420 After Single and Multiple Dose Administration
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT03009760
- Lead Sponsor
- HK inno.N Corporation
- Brief Summary
The purpose of this study is to compare the pharmacokinetics and pharmacodynamics of CJ-12420 after single and multiple dose administration according to H. pylori infection.
- Detailed Description
1. Cohort 1: To investigate the pharmacokinetics and pharmacodynamics of CJ-12420 after the multiple dose administration in H. pylori negative volunteers.
2. Cohort 2: To investigate the pharmacokinetics and pharmacodynamics of CJ-12420 after the single dose administration in H. pylori positive volunteers.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 16
-
Healthy male volunteers between 20 to 45 years of age (inclusive)
-
Body mass index (BMI) in the range of 19~28 kg/㎡ and weighted at least 50kg
-
Medically healthy with no clinically significant vital signs (blood pressure in the sitting position, 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
-
Understood the requirements of the study and voluntarily consented to participate in the study
-
Agreed to be sexually abstinent or to use a condom or spermicide when engaging in sexual activity and not to donate sperm during the course of the study for 30 days following completion of the study
-
Non-smokers or non-users of nicotine-containing products for at least 1 year
-
[Cohort 1] H. pylori negative as determined by urea breath test and serum IgG antibody
-
[Cohort 2] H. pylori positive as determined by urea breath test and serum IgG
- History of clinically significant gastrointestinal, renal, hepatic, neurologic, hemato-oncologic, endocrine, pulmonary, immunologic, psychiatric, musculoskeletal, or cardiovascular disease or any other condition, which in the opinion of the investigators, would jeopardize the safety of the subject or impact the validity of the study results
- History of allergy or hypersensitivity to any drug, including prior serious adverse reaction to PPIs or P-CABs
- Undergone surgery or in a medical condition, which in the judgment of the PI or investigators may affect absorption, distribution, metabolism or elimination of the study drug
- Administered other drug(s) in other clinical study within 60 days prior to screening visit
- Donated blood within 60 days or blood components within 30 days, or had been transfused plasma within 30 days prior to screening visit
- On special diet or have experienced substantial changes in eating habits within 30 days prior to screening visit
- Used any prescription medication within 14 days, or any other OTC medications including herbal products within 7 days prior to screening visit
- Consumed over 21 units/week of alcohol
- Consumed over 5 units/day of caffeine-containing beverage
- Positive urine screen for drugs and/or cotinine
- Positive blood screen for human immunodeficiency virus (HIV), hepatitis B or C, or syphilis
- Clinically significant abnormalities of liver function tests (≥1.5 fold of normal upper limit in the level of L-alanine aminotransferase (ALT), L-aspartate aminotransferase (AST) or total bilirubin)
- Unable to bear pH meter catheter insertion
- History of symptomatic GERD, erosive esophagitis, duodenal ulcer, gastric ulcer, Barrett's esophagus, or Zollinger-Ellison syndrome
- Clinically significant observations considered as unsuitable based on medical judgment by investigators
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CJ-12420 100mg(HP+) CJ-12420 100mg(HP+) CJ-12420 100mg in H. pylori positive subject CJ-12420 50mg(HP+) CJ-12420 50mg(HP+) CJ-12420 50mg in H. pylori positive subject CJ-12420 50mg(HP-) CJ-12420 50mg(HP-) CJ-12420 50mg in H. pylori negative subject CJ-12420 100mg(HP-) CJ-12420 100mg(HP-) CJ-12420 100mg in H. pylori negative subject
- Primary Outcome Measures
Name Time Method Peak Plasma Concentration (Cmax) of CJ-12420 up to 12 hours
- Secondary Outcome Measures
Name Time Method Half life(t1/2β) of CJ-12420 up to 12 hours Area under the plasma concentration versus time curve (AUC) of CJ-12420 up to 12 hours Time at pH > 4(%) Day -1, Day 1, Day 7 up to 24 hours the percent of time the pH as data from the pH probe monitoring
Time of maximum observed concentration(tmax) of CJ-12420 up to 12 hours Mean pH Day -1, Day 1, Day 7 up to 24 hours Data from the pH probe monitoring
Time at pH > 6(%) Day -1, Day 1, Day 7 up to 24 hours the percent of time the pH as data from the pH probe monitoring