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

HK inno.N

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: CJ-12420 200mg; Drug: CJ-12420 200mg + Clarithromycin 500mg; Drug: Clarithromycin 500mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02052336

CJ_APA_103

Details and patient eligibility

About

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 description

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

Enrollment: 24 patients

Sex: Male

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

CJ-12420 200 mg + Clarithromycin 500mg

Experimental group

Description:

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

Treatment:

Drug: Clarithromycin 500mg

Drug: CJ-12420 200mg

CJ-12420 200mg

Active Comparator group

Description:

CJ-12420 200mg QD for 5 days

Treatment:

Drug: Clarithromycin 500mg

Drug: CJ-12420 200mg + Clarithromycin 500mg

Clarithromycin 500mg

Active Comparator group

Description:

Clarithromycin 500mg BID for 5 days

Treatment:

Drug: CJ-12420 200mg + Clarithromycin 500mg

Drug: CJ-12420 200mg