Clinical trial NCT02052336: Drug-Drug Interaction Study Between CJ-12420 and Clarithromycin in Healthy Male Subjects
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Drug-Drug interaction
Pharmacokinetics
Lead sponsor: HK inno.N Corporation
Sponsor class: INDUSTRY
First posted: 2014-02-03
Enrollment: 24
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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

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

Eligibility 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)

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
timeFrame: 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
timeFrame: 6 days after last visit
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Inje university college of medicine Busan Paik Hospital
Study officials:
References: