Overview

This trial is active, not recruiting.

Condition healthy
Treatments cj-12420 200mg + clarithromycin 500mg, cj-12420 200mg, clarithromycin 500mg
Phase phase 1
Sponsor CJ HealthCare Corporation
Start date October 2013
End date January 2014
Trial size 24 participants
Trial identifier NCT02052336, CJ_APA_103

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacokinetics study
Intervention model crossover assignment
Masking open label
Primary purpose basic science
Arm
(Experimental)
CJ-12420 200mg QD for 5 days + Clarithromycin 500mg BID for 5 days
cj-12420 200mg CJ-12420 200mg for 5 days
To assess the effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin.
clarithromycin 500mg Clarithromycin 500mg for 5 days
To assess the effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin.
(Active Comparator)
CJ-12420 200mg QD for 5 days
cj-12420 200mg + clarithromycin 500mg CJ-12420 200mg for 5 days + Clarithromycin 500mg for 5 days
To assess the effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin.
clarithromycin 500mg Clarithromycin 500mg for 5 days
To assess the effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin.
(Active Comparator)
Clarithromycin 500mg BID for 5 days
cj-12420 200mg + clarithromycin 500mg CJ-12420 200mg for 5 days + Clarithromycin 500mg for 5 days
To assess the effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin.
cj-12420 200mg CJ-12420 200mg for 5 days
To assess the effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin.

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
The safety of the coadministration of multiple dose of CJ-12420 and clarithromycin in healthy subjects
time frame: 6 days after last visit

Eligibility Criteria

Male participants from 19 years up to 45 years old.

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)

Additional Information

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
Description An open-label, randomized, 6-sequence, 3-period, 3-treatment crossover design
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by CJ HealthCare Corporation.