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

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2014

Detailed Description

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

Interventions

  • Drug: CJ-12420 200mg + Clarithromycin 500mg
    • To assess the effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin.
  • Drug: CJ-12420 200mg
    • To assess the effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin.
  • Drug: Clarithromycin 500mg
    • To assess the effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin.

Arms, Groups and Cohorts

  • Experimental: CJ-12420 200 mg + Clarithromycin 500mg
    • CJ-12420 200mg QD for 5 days + Clarithromycin 500mg BID for 5 days
  • Active Comparator: CJ-12420 200mg
    • CJ-12420 200mg QD for 5 days
  • Active Comparator: Clarithromycin 500mg
    • Clarithromycin 500mg BID for 5 days

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • The safety of the coadministration of multiple dose of CJ-12420 and clarithromycin in healthy subjects
    • Time Frame: 6 days after last visit
    • 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.

Participating in This Clinical Trial

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)

Gender Eligibility: Male

Minimum Age: 19 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • HK inno.N Corporation
  • Provider of Information About this Clinical Study
    • Sponsor

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