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

Drug Interaction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03011996
• Other study ID #: CJ_APA_107
• Status: Completed
• Phase: Phase 1
• First received: December 13, 2016
• Last updated: May 11, 2017
• Start date: May 2016
• Est. completion date: February 2017

Study information

• Verified date: May 2017
• Source: CJ HealthCare Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Drug Interaction
• Pharmacodynamic
• Pharmacokinetic

Intervention

Drug:
• CLR 500mg
Cohort 1: bid for 5 days Cohort 2: bid for 7 days
• CJ-12420 100mg
Cohort 1: bid for 5 days Cohort 2: bid for 7 days
• CJ-12420 50mg
Cohort 2: bid for 7 days
• AMX 1g
Cohort 1: bid for 5 days Cohort 2: bid for 7 days
• Pantoprazole 40mg
Cohort 2: bid for 7 days

Locations

Country	Name	City	State
Korea, Republic of	Inje University Busan Baik Hospital	Busan

Sponsors (1)

Lead Sponsor	Collaborator
CJ HealthCare Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Plasma Concentration (Cmax) of CJ-12420, clarithromycin and amoxicillin		Up to 120 hours
Secondary	Area under the plasma concentration versus time curve (AUC) of CJ-12420, clarithromycin and amoxicillin		Up to 120 hours
Secondary	Time of maximum observed concentraion(tmax) of CJ-12420, clarithromycin and amoxicillin		Up to 120 hours
Secondary	Half life(t1/2) of CJ-12420, clarithromycin and amoxicillin		Up to 120 hours
Secondary	Oral clearance at steady state(CLss/F) of CJ-12420, clarithromycin and amoxicillin		Up to 120 hours
Secondary	Apparent volume of distribution at steady state(Vdss/F) of CJ-12420, clarithromycin and amoxicillin		Up to 120 hours
Secondary	median pH	Data from the pH probe monitoring	Up to 24 hours
Secondary	Time at pH > 3 (%)	the percent of time the pH as data from the pH probe monitoring	Day -1, Day 1, Day 7 up to 24 hours
Secondary	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
Secondary	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