NCT03011996

Brief Summary

Cohort 1 To evaluate the pharmacokinetic interactions of CJ-12420 after multiple oral doses of CJ-12420 given alone or in combination with amoxicillin/clarithromycin in healthy subjects. Cohort 2 To evaluate the pharmacodynamic profiles of CJ-12420 after multiple oral doses of CJ-12420 in combination with amoxicillin/clarithromycin in healthy subjects as compared to an active control group, i.e., pantoprazole in combination with amoxicillin/clarithromycin.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2016

Completed
24 days until next milestone

First Posted

Study publicly available on registry

January 6, 2017

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

May 12, 2017

Status Verified

May 1, 2017

Enrollment Period

9 months

First QC Date

December 13, 2016

Last Update Submit

May 11, 2017

Conditions

Drug InteractionPharmacokineticPharmacodynamic

Outcome Measures

Primary Outcomes (1)

  • Peak Plasma Concentration (Cmax) of CJ-12420, clarithromycin and amoxicillin

    Up to 120 hours

Secondary Outcomes (9)

  • Area under the plasma concentration versus time curve (AUC) of CJ-12420, clarithromycin and amoxicillin

    Up to 120 hours

  • Time of maximum observed concentraion(tmax) of CJ-12420, clarithromycin and amoxicillin

    Up to 120 hours

  • Half life(t1/2) of CJ-12420, clarithromycin and amoxicillin

    Up to 120 hours

  • Oral clearance at steady state(CLss/F) of CJ-12420, clarithromycin and amoxicillin

    Up to 120 hours

  • Apparent volume of distribution at steady state(Vdss/F) of CJ-12420, clarithromycin and amoxicillin

    Up to 120 hours

  • +4 more secondary outcomes

Study Arms (6)

CJ-12420 100mg

EXPERIMENTAL

CJ-12420 100mg BID for 5 days

Drug: CJ-12420 100mg

CJ-12420 50mg + CLR 500mg + AMX 1g

EXPERIMENTAL

coadministration of CJ-12420 50mg and CLR 500mg/AMX 1g BID for 7 days

Drug: CLR 500mgDrug: CJ-12420 50mgDrug: AMX 1g

Pantoprazole 40mg + CLR 500mg + AMX 1g

ACTIVE COMPARATOR

coadministration of Pantoprazole 40mg and CLR 500mg/AMX 1g BID for 7 days

Drug: CLR 500mgDrug: AMX 1gDrug: Pantoprazole 40mg

CJ-12420 100mg + CLR 500mg + AMX 1g

EXPERIMENTAL

coadministration of CJ-12420 100mg, CLR 500mg/AMX 1g BID for 7 days

Drug: CLR 500mgDrug: CJ-12420 100mgDrug: AMX 1g

CLR 500mg/AMX 1g

EXPERIMENTAL

CLR 500mg/AMX 1g BID for 5 days

Drug: CLR 500mgDrug: AMX 1g

CJ-12420 100mg + CLR 500mg/AMX 1g

EXPERIMENTAL

coadministration of CJ-12420 100mg and CLR 500mg/AMX 1g BID for 7 days

Drug: CLR 500mgDrug: CJ-12420 100mgDrug: AMX 1g

Interventions

CLR 500mgDRUG

Cohort 1: bid for 5 days Cohort 2: bid for 7 days

Also known as: Clarithromycin 500mg
CJ-12420 100mg + CLR 500mg + AMX 1gCJ-12420 100mg + CLR 500mg/AMX 1gCJ-12420 50mg + CLR 500mg + AMX 1gCLR 500mg/AMX 1gPantoprazole 40mg + CLR 500mg + AMX 1g
CJ-12420 100mgDRUG

Cohort 1: bid for 5 days Cohort 2: bid for 7 days

CJ-12420 100mgCJ-12420 100mg + CLR 500mg + AMX 1gCJ-12420 100mg + CLR 500mg/AMX 1g
CJ-12420 50mgDRUG

Cohort 2: bid for 7 days

CJ-12420 50mg + CLR 500mg + AMX 1g
AMX 1gDRUG

Cohort 1: bid for 5 days Cohort 2: bid for 7 days

Also known as: Amoxicillin 1g
CJ-12420 100mg + CLR 500mg + AMX 1gCJ-12420 100mg + CLR 500mg/AMX 1gCJ-12420 50mg + CLR 500mg + AMX 1gCLR 500mg/AMX 1gPantoprazole 40mg + CLR 500mg + AMX 1g
Pantoprazole 40mgDRUG

Cohort 2: bid for 7 days

Pantoprazole 40mg + CLR 500mg + AMX 1g

Eligibility Criteria

Age19 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male volunteers aged ≥19 and ≤45 years at screening;
  • No congenital or chronic disease, and no morbid symptoms or findings on screening tests;
  • Body mass index (BMI) ≥18.5 and ≤28 kg/m2;
  • Considered eligible based on medical examinations (including interview, vital signs, 12-lead ECG, physical exam and laboratory tests) which are set and performed in accordance with the nature of investigational product by the investigator;
  • Voluntary consent to participate in the study after being fully informed of purpose and procedures of the study, and profiles of investigational product prior to the participation;
  • For Cohort 2, positive on 13C urea breath test.

You may not qualify if:

  • Medical history
  • History or current evidence for diseases considered clinically relevant by the investigator including hepatic, renal, gastrointestinal, respiratory, musculoskeletal, endocrine, neurologic, hemato-oncological, urinary, or cardiovascular (including cardiac arrhythmia) diseases;
  • History of gastrointestinal diseases (such as gastritis, gastrodynia, gastroesophageal reflux disease, Crohn's disease and ulcer) or abdominal surgery (except for simple appendectomy or herniotomy) which are considered to have potential effect on drug absorption by the investigator;
  • For Cohort 2, previous treatment failure for H. pylori eradication.
  • Laboratory tests and ECG
  • AST or ALT ≥ 1.25 x upper limit of normal (ULN);
  • Total bilirubin ≥ 1.5 x ULN;
  • eGFR calculated by CKD-EPI formula \< 80 mL/min;
  • Any clinically relevant ECG abnormalities.
  • Allergy and drug abuse
  • History of hypersensitivity to drugs containing investigational products (penicillins, cephems, macrolides, pantoprazole and benzimidazole) and other drugs (including aspirin and antibiotics);
  • History of drug abuse or positive on drug screening test.
  • Drug/dietary restrictions
  • Medications (including herbal supplements) or abnormal diet (e.g., grapefruit juice \> 1 L/day, excessive garlic, broccoli, kale, etc.) which may have effect on absorption, distribution, metabolism and excretion of investigational products within 28 days prior to the first study dose;
  • Use of prescription drugs, over-the-counter drugs (OTCs) or vitamins within 10 days prior to the first study dose;
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inje University Busan Baik Hospital

Busan, South Korea

Location

MeSH Terms

Interventions

ClarithromycinAmoxicillinPantoprazole

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic ChemicalsAmpicillinPenicillin GPenicillinsbeta-LactamsLactamsAmidesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesPyridinesHeterocyclic Compounds, 1-RingBenzimidazoles

Study Officials

  • Jae-Gook Shin

    Inje university college of medicine Busan Paik Hospital

    PRINCIPAL INVESTIGATOR

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

December 13, 2016

First Posted

January 6, 2017

Study Start

May 1, 2016

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

May 12, 2017

Record last verified: 2017-05

Locations

KR(1)