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

NCT02052336 | Completed Phase 1

• 1 other identifier: CJ_APA_103
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Keywords

Drug-Drug interaction; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The safety of the coadministration of multiple dose of CJ-12420 and clarithromycin in healthy subjects

  6 days after last visit

Study Arms (3)

CJ-12420 200 mg + Clarithromycin 500mg

EXPERIMENTAL

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

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

CJ-12420 200mg

ACTIVE COMPARATOR

CJ-12420 200mg QD for 5 days

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

Clarithromycin 500mg

ACTIVE COMPARATOR

Clarithromycin 500mg BID for 5 days

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

Interventions

CJ-12420 200mg + Clarithromycin 500mg DRUG

To assess the effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin.

Also known as: CJ-12420 200mg for 5 days + Clarithromycin 500mg for 5 days

CJ-12420 200mg; Clarithromycin 500mg

CJ-12420 200mg DRUG

To assess the effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin.

Also known as: CJ-12420 200mg for 5 days

CJ-12420 200 mg + Clarithromycin 500mg; Clarithromycin 500mg

Clarithromycin 500mg DRUG

To assess the effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin.

Also known as: Clarithromycin 500mg for 5 days

CJ-12420 200 mg + Clarithromycin 500mg; CJ-12420 200mg

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• HK inno.N Corporation: lead

Study Sites (1)

Inje university college of medicine Busan Paik Hospital

Busan, South Korea

Location

Related Publications (1)

• Oh M, Lee H, Kim S, Kim B, Song GS, Shin JG, Ghim JL. Evaluation of pharmacokinetic drug-drug interaction between tegoprazan and clarithromycin in healthy subjects. Transl Clin Pharmacol. 2023 Jun;31(2):114-123. doi: 10.12793/tcp.2023.31.e11. Epub 2023 Jun 27.

  PMID: 37440779 DERIVED

MeSH Terms

Interventions

Clarithromycin

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2014
• First Posted: February 3, 2014
• Study Start: October 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: November 1, 2014
• Last Updated: December 15, 2016

Record last verified: 2016-12

Locations

KR (1)