NCT03009760CompletedPhase 1
A Phase I , Study to Investigate Pharmacokinetics and Pharmacodynamics of Single and Multiple Dose of CJ-12420 50mg, 100mg in Helicobacter Pylori ?
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- HK inno.N Corporation
- Enrollment
- 16
- Primary Endpoint
- Peak Plasma Concentration (Cmax) of CJ-12420
Study Overview
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
- Cohort 1: To investigate the pharmacokinetics and pharmacodynamics of CJ-12420 after the multiple dose administration in H. pylori negative volunteers.
- Cohort 2: To investigate the pharmacokinetics and pharmacodynamics of CJ-12420 after the single dose administration in H. pylori positive volunteers.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 45 Years (Adult)
- Sex
- Male
- Accepts 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
Arms & Interventions
CJ-12420 50mg(HP-)
Experimental
CJ-12420 50mg in H. pylori negative subject
Intervention: CJ-12420 50mg(HP-) (Drug)
CJ-12420 100mg(HP-)
Experimental
CJ-12420 100mg in H. pylori negative subject
Intervention: CJ-12420 100mg(HP-) (Drug)
CJ-12420 50mg(HP+)
Experimental
CJ-12420 50mg in H. pylori positive subject
Intervention: CJ-12420 50mg(HP+) (Drug)
CJ-12420 100mg(HP+)
Experimental
CJ-12420 100mg in H. pylori positive subject
Intervention: CJ-12420 100mg(HP+) (Drug)
Outcomes
Primary Outcomes
Peak Plasma Concentration (Cmax) of CJ-12420
Time Frame: up to 12 hours
Secondary Outcomes
- 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)
- 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)
- Time at pH > 6(%)(Day -1, Day 1, Day 7 up to 24 hours)
Investigators
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