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

Sponsor
HK inno.N Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT02052336
Collaborator
(none)
24
Enrollment
1
Location
3
Arms
13
Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: CJ-12420 200mg + Clarithromycin 500mg
  • Drug: CJ-12420 200mg
  • Drug: Clarithromycin 500mg
 Phase 1

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
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 Start Date :
Oct 1, 2013
Actual Primary Completion Date :
Jan 1, 2014
Actual Study Completion Date :
Nov 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: CJ-12420 200 mg + Clarithromycin 500mg

CJ-12420 200mg QD for 5 days + Clarithromycin 500mg BID for 5 days

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.
Other Names:
  • CJ-12420 200mg for 5 days

    • 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.
    Other Names:
  • Clarithromycin 500mg for 5 days

    		•
    Active Comparator: CJ-12420 200mg

    CJ-12420 200mg QD for 5 days

    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.
    Other Names:
  • CJ-12420 200mg for 5 days + Clarithromycin 500mg for 5 days

    • 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.
    Other Names:
  • Clarithromycin 500mg for 5 days

    		•
    Active Comparator: Clarithromycin 500mg

    Clarithromycin 500mg BID for 5 days

    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.
    Other Names:
  • CJ-12420 200mg for 5 days + Clarithromycin 500mg for 5 days

    • 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.
    Other Names:
  • CJ-12420 200mg for 5 days

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin [Blood sampling during 12 or 24hrs after administration]

      Cmax, Cmin, Tmax, AUC(tau), CL/F, T1/2

    Secondary Outcome Measures

    1. The safety of the coadministration of multiple dose of CJ-12420 and clarithromycin in healthy subjects [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 45 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Inje university college of medicine Busan Paik Hospital Busan Korea, Republic of

    Sponsors and Collaborators

    • HK inno.N Corporation

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    HK inno.N Corporation
    ClinicalTrials.gov Identifier:
    NCT02052336
    Other Study ID Numbers:
    • CJ_APA_103
    First Posted:
    Feb 3, 2014
    Last Update Posted:
    Dec 15, 2016
    Last Verified:
    Dec 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by HK inno.N Corporation
    Drug-Drug interaction
    Pharmacokinetics
    Additional relevant MeSH terms:
    Clarithromycin

    Study Results

    No Results Posted as of Dec 15, 2016