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To Investigate PK and PD of CJ-12420, Clarithromycin, Amoxicillin After Multiple Dose Administration

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ClinicalTrials.gov Identifier: NCT03011996
Recruitment Status : Completed
First Posted : January 6, 2017
Last Update Posted : May 12, 2017
Sponsor:
Information provided by (Responsible Party):
CJ HealthCare Corporation

Tracking Information
First Submitted Date  ICMJE December 13, 2016
First Posted Date  ICMJE January 6, 2017
Last Update Posted Date May 12, 2017
Actual Study Start Date  ICMJE May 2016
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2017)
Peak Plasma Concentration (Cmax) of CJ-12420, clarithromycin and amoxicillin [ Time Frame: Up to 120 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03011996 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2017)
  • Area under the plasma concentration versus time curve (AUC) of CJ-12420, clarithromycin and amoxicillin [ Time Frame: Up to 120 hours ]
  • Time of maximum observed concentraion(tmax) of CJ-12420, clarithromycin and amoxicillin [ Time Frame: Up to 120 hours ]
  • Half life(t1/2) of CJ-12420, clarithromycin and amoxicillin [ Time Frame: Up to 120 hours ]
  • Oral clearance at steady state(CLss/F) of CJ-12420, clarithromycin and amoxicillin [ Time Frame: Up to 120 hours ]
  • Apparent volume of distribution at steady state(Vdss/F) of CJ-12420, clarithromycin and amoxicillin [ Time Frame: Up to 120 hours ]
  • median pH [ Time Frame: Up to 24 hours ]
    Data from the pH probe monitoring
  • Time at pH > 3 (%) [ Time Frame: 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 > 4 (%) [ Time Frame: 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 (%) [ Time Frame: Day -1, Day 1, Day 7 up to 24 hours ]
    the percent of time the pH as data from the pH probe monitoring
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE To Investigate PK and PD of CJ-12420, Clarithromycin, Amoxicillin After Multiple Dose Administration
Official Title  ICMJE An Open-label, Randomized Study to Evaluate Pharmacokinetic Interaction, Pharmacodynamics and Safety After Multiple Oral Dosing of CJ-12420 and Amoxicillin/Clarithromycin in Healthy Subjects
Brief Summary

Cohort 1

To evaluate the pharmacokinetic interactions of CJ-12420 after multiple oral doses of CJ-12420 given alone or in combination with amoxicillin/clarithromycin in healthy subjects.

Cohort 2

To evaluate the pharmacodynamic profiles of CJ-12420 after multiple oral doses of CJ-12420 in combination with amoxicillin/clarithromycin in healthy subjects as compared to an active control group, i.e., pantoprazole in combination with amoxicillin/clarithromycin.

Detailed Description To evaluate the pharmacokinetic the drug-drug interaction of CJ-12420 and amoxicillin/clarithromycin and investigate the pharmacodynamic of co-administration of CJ-12420 and amoxicillin and clarithromycin.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Drug Interaction
  • Pharmacokinetic
  • Pharmacodynamic
Intervention  ICMJE
  • Drug: CLR 500mg
    Cohort 1: bid for 5 days Cohort 2: bid for 7 days
    Other Name: Clarithromycin 500mg
  • Drug: CJ-12420 100mg
    Cohort 1: bid for 5 days Cohort 2: bid for 7 days
  • Drug: CJ-12420 50mg
    Cohort 2: bid for 7 days
  • Drug: AMX 1g
    Cohort 1: bid for 5 days Cohort 2: bid for 7 days
    Other Name: Amoxicillin 1g
  • Drug: Pantoprazole 40mg
    Cohort 2: bid for 7 days
Study Arms  ICMJE
  • Experimental: CJ-12420 100mg
    CJ-12420 100mg BID for 5 days
    Intervention: Drug: CJ-12420 100mg
  • Experimental: CJ-12420 50mg + CLR 500mg + AMX 1g
    coadministration of CJ-12420 50mg and CLR 500mg/AMX 1g BID for 7 days
    Interventions:
    • Drug: CLR 500mg
    • Drug: CJ-12420 50mg
    • Drug: AMX 1g
  • Active Comparator: Pantoprazole 40mg + CLR 500mg + AMX 1g
    coadministration of Pantoprazole 40mg and CLR 500mg/AMX 1g BID for 7 days
    Interventions:
    • Drug: CLR 500mg
    • Drug: AMX 1g
    • Drug: Pantoprazole 40mg
  • Experimental: CJ-12420 100mg + CLR 500mg + AMX 1g
    coadministration of CJ-12420 100mg, CLR 500mg/AMX 1g BID for 7 days
    Interventions:
    • Drug: CLR 500mg
    • Drug: CJ-12420 100mg
    • Drug: AMX 1g
  • Experimental: CLR 500mg/AMX 1g
    CLR 500mg/AMX 1g BID for 5 days
    Interventions:
    • Drug: CLR 500mg
    • Drug: AMX 1g
  • Experimental: CJ-12420 100mg + CLR 500mg/AMX 1g
    coadministration of CJ-12420 100mg and CLR 500mg/AMX 1g BID for 7 days
    Interventions:
    • Drug: CLR 500mg
    • Drug: CJ-12420 100mg
    • Drug: AMX 1g
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 4, 2017)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2017
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Healthy male volunteers aged ≥19 and ≤45 years at screening;
  2. No congenital or chronic disease, and no morbid symptoms or findings on screening tests;
  3. Body mass index (BMI) ≥18.5 and ≤28 kg/m2;
  4. Considered eligible based on medical examinations (including interview, vital signs, 12-lead ECG, physical exam and laboratory tests) which are set and performed in accordance with the nature of investigational product by the investigator;
  5. Voluntary consent to participate in the study after being fully informed of purpose and procedures of the study, and profiles of investigational product prior to the participation;
  6. For Cohort 2, positive on 13C urea breath test.

Exclusion Criteria:

  1. Medical history

    1. History or current evidence for diseases considered clinically relevant by the investigator including hepatic, renal, gastrointestinal, respiratory, musculoskeletal, endocrine, neurologic, hemato-oncological, urinary, or cardiovascular (including cardiac arrhythmia) diseases;
    2. History of gastrointestinal diseases (such as gastritis, gastrodynia, gastroesophageal reflux disease, Crohn's disease and ulcer) or abdominal surgery (except for simple appendectomy or herniotomy) which are considered to have potential effect on drug absorption by the investigator;
    3. For Cohort 2, previous treatment failure for H. pylori eradication.
  2. Laboratory tests and ECG

    1. AST or ALT ≥ 1.25 x upper limit of normal (ULN);
    2. Total bilirubin ≥ 1.5 x ULN;
    3. eGFR calculated by CKD-EPI formula < 80 mL/min;
    4. Any clinically relevant ECG abnormalities.
  3. Allergy and drug abuse

    1. History of hypersensitivity to drugs containing investigational products (penicillins, cephems, macrolides, pantoprazole and benzimidazole) and other drugs (including aspirin and antibiotics);
    2. History of drug abuse or positive on drug screening test.
  4. Drug/dietary restrictions

    1. Medications (including herbal supplements) or abnormal diet (e.g., grapefruit juice > 1 L/day, excessive garlic, broccoli, kale, etc.) which may have effect on absorption, distribution, metabolism and excretion of investigational products within 28 days prior to the first study dose;
    2. Use of prescription drugs, over-the-counter drugs (OTCs) or vitamins within 10 days prior to the first study dose;
    3. Participating in other study and receive investigational product within 3 months prior to the first study dose.
  5. Blood donation and transfusion

    1. Whole blood donation within 60 days prior to the first study dose;
    2. Donation of blood components or transfusion within 30 days prior to the first study dose.
  6. Pregnancy and contraception

    1. Pregnant or breast-feeding;
    2. Subject or his partner's inability to use of medically qualifying dual-contraceptive methods or medically acceptable contraception (including intrauterine device with established pregnancy failure rate, barrier methods with spermicide, vasectomy, tubectomy, tubal ligation and hysterectomy) from screening to 30 days of the last dose of investigational product.
  7. Others

    1. Heavy use of alcohol (average alcohol intake ≥30 g/day) or positive on alcohol test;
    2. Heavy smoker (>10 cigarettes/day);
    3. Caffeine intake > 400 mg/day;
    4. Any clinically relevant findings considered inappropriate for study participation at the discretion of the investigator.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03011996
Other Study ID Numbers  ICMJE CJ_APA_107
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party CJ HealthCare Corporation
Study Sponsor  ICMJE CJ HealthCare Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jae-Gook Shin Inje university college of medicine Busan Paik Hospital
PRS Account CJ HealthCare Corporation
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP