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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

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.


Condition or disease Intervention/treatment Phase
Drug Interaction Pharmacokinetic Pharmacodynamic Drug: CLR 500mg Drug: CJ-12420 100mg Drug: CJ-12420 50mg Drug: AMX 1g Drug: Pantoprazole 40mg Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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
Actual Study Start Date : May 2016
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CJ-12420 100mg
CJ-12420 100mg BID for 5 days
Drug: CJ-12420 100mg
Cohort 1: bid for 5 days Cohort 2: bid for 7 days

Experimental: CJ-12420 50mg + CLR 500mg + AMX 1g
coadministration of CJ-12420 50mg and CLR 500mg/AMX 1g BID for 7 days
Drug: CLR 500mg
Cohort 1: bid for 5 days Cohort 2: bid for 7 days
Other Name: Clarithromycin 500mg

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

Active Comparator: Pantoprazole 40mg + CLR 500mg + AMX 1g
coadministration of Pantoprazole 40mg and CLR 500mg/AMX 1g BID for 7 days
Drug: CLR 500mg
Cohort 1: bid for 5 days Cohort 2: bid for 7 days
Other Name: Clarithromycin 500mg

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

Experimental: CJ-12420 100mg + CLR 500mg + AMX 1g
coadministration of CJ-12420 100mg, CLR 500mg/AMX 1g BID for 7 days
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: AMX 1g
Cohort 1: bid for 5 days Cohort 2: bid for 7 days
Other Name: Amoxicillin 1g

Experimental: CLR 500mg/AMX 1g
CLR 500mg/AMX 1g BID for 5 days
Drug: CLR 500mg
Cohort 1: bid for 5 days Cohort 2: bid for 7 days
Other Name: Clarithromycin 500mg

Drug: AMX 1g
Cohort 1: bid for 5 days Cohort 2: bid for 7 days
Other Name: Amoxicillin 1g

Experimental: CJ-12420 100mg + CLR 500mg/AMX 1g
coadministration of CJ-12420 100mg and CLR 500mg/AMX 1g BID for 7 days
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: AMX 1g
Cohort 1: bid for 5 days Cohort 2: bid for 7 days
Other Name: Amoxicillin 1g




Primary Outcome Measures :
  1. Peak Plasma Concentration (Cmax) of CJ-12420, clarithromycin and amoxicillin [ Time Frame: Up to 120 hours ]

Secondary Outcome Measures :
  1. Area under the plasma concentration versus time curve (AUC) of CJ-12420, clarithromycin and amoxicillin [ Time Frame: Up to 120 hours ]
  2. Time of maximum observed concentraion(tmax) of CJ-12420, clarithromycin and amoxicillin [ Time Frame: Up to 120 hours ]
  3. Half life(t1/2) of CJ-12420, clarithromycin and amoxicillin [ Time Frame: Up to 120 hours ]
  4. Oral clearance at steady state(CLss/F) of CJ-12420, clarithromycin and amoxicillin [ Time Frame: Up to 120 hours ]
  5. Apparent volume of distribution at steady state(Vdss/F) of CJ-12420, clarithromycin and amoxicillin [ Time Frame: Up to 120 hours ]
  6. median pH [ Time Frame: Up to 24 hours ]
    Data from the pH probe monitoring

  7. 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

  8. 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

  9. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03011996


Locations
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Korea, Republic of
Inje University Busan Baik Hospital
Busan, Korea, Republic of
Sponsors and Collaborators
CJ HealthCare Corporation
Investigators
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Principal Investigator: Jae-Gook Shin Inje university college of medicine Busan Paik Hospital

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Responsible Party: CJ HealthCare Corporation
ClinicalTrials.gov Identifier: NCT03011996     History of Changes
Other Study ID Numbers: CJ_APA_107
First Posted: January 6, 2017    Key Record Dates
Last Update Posted: May 12, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Amoxicillin
Clarithromycin
Pantoprazole
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors