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

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ClinicalTrials.gov Identifier: NCT02052336
Recruitment Status : Completed
First Posted : February 3, 2014
Last Update Posted : December 15, 2016
Sponsor:
Information provided by (Responsible Party):
CJ HealthCare Corporation

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
Healthy 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

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Study Type : Interventional  (Clinical Trial)
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 : October 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: CJ-12420 200mg for 5 days




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 [ Time Frame: 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 [ 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.



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:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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)

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): NCT02052336


Locations
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Korea, Republic of
Inje university college of medicine Busan Paik Hospital
Busan, Korea, Republic of
Sponsors and Collaborators
CJ HealthCare Corporation

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Responsible Party: CJ HealthCare Corporation
ClinicalTrials.gov Identifier: NCT02052336     History of Changes
Other Study ID Numbers: CJ_APA_103
First Posted: February 3, 2014    Key Record Dates
Last Update Posted: December 15, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by CJ HealthCare Corporation:
Drug-Drug interaction
Pharmacokinetics

Additional relevant MeSH terms:
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Clarithromycin
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