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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: CJ-12420 200mg; Drug: Clarithromycin 500mg; Drug: CJ-12420 200mg + Clarithromycin 500mg

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
    • Inje University College of Medicine Busan Paik Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / 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: 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; 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
ACTIVE_COMPARATOR: Clarithromycin 500mg; 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: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin	Cmax, Cmin, Tmax, AUC(tau), CL/F, T1/2	Blood sampling during 12 or 24hrs after administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The safety of the coadministration of multiple dose of CJ-12420 and clarithromycin in healthy subjects	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.	6 days after last visit

Collaborators and Investigators

• Sponsor: HK inno.N Corporation

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (ACTUAL): January 1, 2014
• Study Completion (ACTUAL): November 1, 2014

Study Registration Dates

• First Submitted: January 7, 2014
• First Submitted That Met QC Criteria: January 29, 2014
• First Posted (ESTIMATE): February 3, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): December 15, 2016
• Last Update Submitted That Met QC Criteria: December 13, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Drug-Drug interaction
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Clarithromycin
• Other Study ID Numbers: CJ_APA_103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED