Clinical trial NCT03009760: To Investigate Pharmacokinetics and Pharmacodynamics of CJ-12420 After Single and Multiple Dose Administration
Official title: A Phase I , Study to Investigate Pharmacokinetics and Pharmacodynamics of Single and Multiple Dose of CJ-12420 50mg, 100mg in Helicobacter Pylori ?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: HK inno.N Corporation
Sponsor class: INDUSTRY
Collaborators: name: Asan Medical Center
First posted: 2017-01-04
Enrollment: 16
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Peak Plasma Concentration (Cmax) of CJ-12420
timeFrame: up to 12 hours
Secondary outcomes:
measure: Area under the plasma concentration versus time curve (AUC) of CJ-12420
timeFrame: up to 12 hours
measure: Time of maximum observed concentration(tmax) of CJ-12420
timeFrame: up to 12 hours
measure: Half life(t1/2β) of CJ-12420
timeFrame: up to 12 hours
measure: Mean pH
timeFrame: Day -1, Day 1, Day 7 up to 24 hours
measure: Time at pH > 4(%)
timeFrame: Day -1, Day 1, Day 7 up to 24 hours
measure: Time at pH > 6(%)
timeFrame: Day -1, Day 1, Day 7 up to 24 hours
Other outcomes:
Locations:
Study officials:
References: