To Investigate Pharmacokinetics and Pharmacodynamics of CJ-12420 After Single and Multiple Dose Administration

A Phase I , Study to Investigate Pharmacokinetics and Pharmacodynamics of Single and Multiple Dose of CJ-12420 50mg, 100mg in Helicobacter Pylori ?

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: CJ-12420 50mg(HP-); Drug: CJ-12420 100mg(HP-); Drug: CJ-12420 50mg(HP+); Drug: CJ-12420 100mg(HP+)

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CJ-12420 50mg(HP-); CJ-12420 50mg in H. pylori negative subject	Drug: CJ-12420 50mg(HP-); CJ-12420 50mg in H. pylori negative subject; Other Names: not yet determined
Experimental: CJ-12420 100mg(HP-); CJ-12420 100mg in H. pylori negative subject	Drug: CJ-12420 100mg(HP-); CJ-12420 100mg in H. pylori negative subject; Other Names: not yet determined
Experimental: CJ-12420 50mg(HP+); CJ-12420 50mg in H. pylori positive subject	Drug: CJ-12420 50mg(HP+); CJ-12420 50mg in H. pylori positive subject; Other Names: not yet determined
Experimental: CJ-12420 100mg(HP+); CJ-12420 100mg in H. pylori positive subject	Drug: CJ-12420 100mg(HP+); CJ-12420 100mg in H. pylori positive subject; Other Names: not yet determined

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Peak Plasma Concentration (Cmax) of CJ-12420	up to 12 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the plasma concentration versus time curve (AUC) of CJ-12420		up to 12 hours
Time of maximum observed concentration(tmax) of CJ-12420		up to 12 hours
Half life(t1/2β) of CJ-12420		up to 12 hours
Mean pH	Data from the pH probe monitoring	Day -1, Day 1, Day 7 up to 24 hours
Time at pH > 4(%)	the percent of time the pH as data from the pH probe monitoring	Day -1, Day 1, Day 7 up to 24 hours
Time at pH > 6(%)	the percent of time the pH as data from the pH probe monitoring	Day -1, Day 1, Day 7 up to 24 hours

Collaborators and Investigators

• Sponsor: HK inno.N Corporation
• Collaborators: Asan Medical Center

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: December 28, 2016
• First Submitted That Met QC Criteria: January 1, 2017
• First Posted (Estimate): January 4, 2017

Study Record Updates

• Last Update Posted (Estimate): January 20, 2017
• Last Update Submitted That Met QC Criteria: January 19, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: [CJ_APA_104]

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO