Drug-Drug Interaction Study Between CJ-12420 and Clarithromycin in Healthy Male Subjects

Study Overview
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Brief Summary
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Primary Objective: To assess the effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin. Secondary Objective(s): To assess the safety of the coadministration of multiple dose of CJ-12420 and clarithromycin in healthy subjects

Detailed Description
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An open-label, randomized, 6-sequence, 3-period, 3-treatment crossover design

Official Title
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An Open-label, Randomized, 6-Sequence, 3-Period Crossover Study to Evaluate a Pharmacokinetic Drug Interaction Between CJ-12420 and Clarithromycin in Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: CJ-12420 200mg + Clarithromycin 500mg
* Drug: CJ-12420 200mg
* Drug: Clarithromycin 500mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male volunteers in the age between 19 and 45 years old Body mass index(BMI) in the range of 19 to 28 kg/m2 Understand the requirement of the study and voluntarily consent to paticipate in the study Exclusion Criteria: History of clinically significant medical history or disease (hepatic, kidney, gastrointestinal,respiratory, musculoskeletal, endocrine,neuro-psychiatric, haemato-oncologic,urinary tract, cardiac arrhythmia and cardiovascular system) judged by investigator. Clinically significant abnormal laboratory results within at least 28 days prior to the first day of drug administration. AST or ALT > 1.25 times of upper limit value Total bilirubin > 1.5 times of upper limit value estimated GFR :less than 80 mL/min Clinically significant abnormal ECG results within at least 28 days prior to the first day of drug administration PR ≥ 210 msec QRS ≥ 120 msec QT ≥ 500 msec QTcF ≥ 500 msec Clinically significant hypersensitivity reaction against investigational drug or other drugs history of drug abuse or positive results from drug screening test. Take medicine such as prescription medicine or herbal medicine, over-the-counter drug, vitamin supplements Person who have intake history of food or drug which can affect drug absorption, drug distribution, drug metabolism, and drug excretion and bowel activity Volunteer have a history of donation of whole blood donation, apheresis, transfusion Volunteer a heavy drinker(30g/day), smoker(10 cigarettes/day), heavy caffeine consumer(400mg/day)

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CJ-12420 200 mg + Clarithromycin 500mg<br>CJ-12420 200mg QD for 5 days + Clarithromycin 500mg BID for 5 days | Drug: CJ-12420 200mg<br>* To assess the effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin.<br>* Other names: CJ-12420 200mg for 5 days;Drug: Clarithromycin 500mg<br>* To assess the effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin.<br>* Other names: Clarithromycin 500mg for 5 days;|
| Active Comparator: CJ-12420 200mg<br>CJ-12420 200mg QD for 5 days | Drug: CJ-12420 200mg + Clarithromycin 500mg<br>* To assess the effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin.<br>* Other names: CJ-12420 200mg for 5 days + Clarithromycin 500mg for 5 days;Drug: Clarithromycin 500mg<br>* To assess the effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin.<br>* Other names: Clarithromycin 500mg for 5 days;|
| Active Comparator: Clarithromycin 500mg<br>Clarithromycin 500mg BID for 5 days | Drug: CJ-12420 200mg + Clarithromycin 500mg<br>* To assess the effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin.<br>* Other names: CJ-12420 200mg for 5 days + Clarithromycin 500mg for 5 days;Drug: CJ-12420 200mg<br>* To assess the effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin.<br>* Other names: CJ-12420 200mg for 5 days;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin | Cmax, Cmin, Tmax, AUC(tau), CL/F, T1/2 | Blood sampling during 12 or 24hrs after administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The safety of the coadministration of multiple dose of CJ-12420 and clarithromycin in healthy subjects | Safety and tolerability parameters will include laboratory (haematology, clinical chemistry, urinalysis, 12-lead ECG) values at Screening, Day-1 and Day 6 at each period and Follow-up. | 6 days after last visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug-Drug interaction, Pharmacokinetics