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AzTrials

Drug InteractionPhase 1NCT03011996

To Investigate PK and PD of CJ-12420, Clarithromycin, Amoxicillin After Multiple Dose Administration

A Phase 1 study testing CLR 500mg, CJ-12420 100mg and CJ-12420 50mg in people with Drug Interaction and Pharmacokinetic, run by HK inno.N Corporation at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Drug Interaction, Pharmacokinetic, Pharmacodynamic
What is being tested?
CLR 500mg, CJ-12420 100mg and CJ-12420 50mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteSouth Korea
Study dates
May 2016to Feb 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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);
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  • 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;
  • Participating in other study and receive investigational product within 3 months prior to the first study dose.
  • Blood donation and transfusion
  • Whole blood donation within 60 days prior to the first study dose;
  • Donation of blood components or transfusion within 30 days prior to the first study dose.
  • Pregnancy and contraception
  • Pregnant or breast-feeding;
  • Subject or his partner's inability to use of medically qualifying dual-contraceptive methods or medically acceptable contraception (including intrauterine device with established pregnancy failure rate, barrier methods with spermicide, vasectomy, tubectomy, tubal ligation and hysterectomy) from screening to 30 days of the last dose of investigational product.
  • Others
  • Heavy use of alcohol (average alcohol intake ≥30 g/day) or positive on alcohol test;
  • Heavy smoker (>10 cigarettes/day);
  • Caffeine intake > 400 mg/day;
  • Any clinically relevant findings considered inappropriate for study participation at the discretion of the investigator.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Inje University Busan Baik Hospital

    Busan

Other trials in South Korea

About this study

Official title: An Open-label, Randomized Study to Evaluate Pharmacokinetic Interaction, Pharmacodynamics and Safety After Multiple Oral Dosing of CJ-12420 and Amoxicillin/Clarithromycin in Healthy Subjects

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.

Read the detailed description

To evaluate the pharmacokinetic the drug-drug interaction of CJ-12420 and amoxicillin/clarithromycin and investigate the pharmacodynamic of co-administration of CJ-12420 and amoxicillin and clarithromycin.

Being tested
CLR 500mg, CJ-12420 100mg, CJ-12420 50mg, AMX 1g, Pantoprazole 40mg

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CLR 500mgDrug

    Also called Clarithromycin 500mg

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

  • CJ-12420 100mgDrug

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

  • CJ-12420 50mgDrug

    Cohort 2: bid for 7 days

  • AMX 1gDrug

    Also called Amoxicillin 1g

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

  • Pantoprazole 40mgDrug

    Cohort 2: bid for 7 days

Study groups in NCT03011996
Study groupRoleWhat they receive
CJ-12420 100mgExperimentalCJ-12420 100mg BID for 5 days
Receives: Drug: CJ-12420 100mg
CJ-12420 50mg + CLR 500mg + AMX 1gExperimentalcoadministration of CJ-12420 50mg and CLR 500mg/AMX 1g BID for 7 days
Receives: Drug: CLR 500mg; Drug: CJ-12420 50mg; Drug: AMX 1g
Pantoprazole 40mg + CLR 500mg + AMX 1gActive comparatorcoadministration of Pantoprazole 40mg and CLR 500mg/AMX 1g BID for 7 days
Receives: Drug: CLR 500mg; Drug: AMX 1g; Drug: Pantoprazole 40mg
CJ-12420 100mg + CLR 500mg + AMX 1gExperimentalcoadministration of CJ-12420 100mg, CLR 500mg/AMX 1g BID for 7 days
Receives: Drug: CLR 500mg; Drug: CJ-12420 100mg; Drug: AMX 1g
CLR 500mg/AMX 1gExperimentalCLR 500mg/AMX 1g BID for 5 days
Receives: Drug: CLR 500mg; Drug: AMX 1g
CJ-12420 100mg + CLR 500mg/AMX 1gExperimentalcoadministration of CJ-12420 100mg and CLR 500mg/AMX 1g BID for 7 days
Receives: Drug: CLR 500mg; Drug: CJ-12420 100mg; Drug: AMX 1g

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Up to 120 hours

Secondary outcomes (9)

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

    Measured: Up to 120 hours

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

    Measured: Up to 120 hours

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

    Measured: Up to 120 hours

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

    Measured: Up to 120 hours

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

    Measured: Up to 120 hours

  6. median pH

    Data from the pH probe monitoring

    Measured: Up to 24 hours

  7. Time at pH > 3 (%)

    the percent of time the pH as data from the pH probe monitoring

    Measured: Day -1, Day 1, Day 7 up to 24 hours

  8. Time at pH > 4 (%)

    the percent of time the pH as data from the pH probe monitoring

    Measured: Day -1, Day 1, Day 7 up to 24 hours

  9. Time at pH > 6 (%)

    the percent of time the pH as data from the pH probe monitoring

    Measured: Day -1, Day 1, Day 7 up to 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2017 (estimated)
  2. Study startMay 2016
  3. Primary completionFeb 2017
  4. Study completionFeb 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03011996
Sponsor's protocol ID
CJ_APA_107
Status last verified
May 2017
First submitted
13 Dec 2016
Last updated
12 May 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CLR 500mg, CJ-12420 100mg and CJ-12420 50mg in people with Drug Interaction and Pharmacokinetic, run by HK inno.N Corporation at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peak Plasma Concentration (Cmax) of CJ-12420, clarithromycin and amoxicillin (time frame: Up to 120 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03011996.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2017.

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