Healthy
Conditions
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.
Interventions
DRUGCJ-12420 50mg(HP-)
CJ-12420 50mg in H. pylori negative subject
DRUGCJ-12420 100mg(HP-)
CJ-12420 100mg in H. pylori negative subject
DRUGCJ-12420 50mg(HP+)
CJ-12420 50mg in H. pylori positive subject
DRUGCJ-12420 100mg(HP+)
CJ-12420 100mg in H. pylori positive subject
Sponsors
Asan Medical Center
HK inno.N Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak Plasma Concentration (Cmax) of CJ-12420 | up to 12 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time of maximum observed concentration(tmax) of CJ-12420 | up to 12 hours | — |
| 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 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 |
| Mean pH | Day -1, Day 1, Day 7 up to 24 hours | Data from the pH probe monitoring |
Outcome results
None listed