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Helicobacter Pylori Associated Gastrointestinal DiseasePhase 1NCT05194046

Drug-drug Interactions and Safety Among JP-1366, Amoxicillin, and Clarithromycin in Healthy Volunteers

A Phase 1 study testing JP-1366 20mg 1capsule, Amoxicillin 500Mg Cap and Clarithromycin 500Mg Tab in people with Helicobacter Pylori Associated Gastrointestinal Disease, run by Onconic Therapeutics Inc. 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

To evaluate the effect of coadministration of amoxicillin and clarithromycin on safety, tolerability and pharmacokinetics of JP-1366 in healthy subjects and the effect of JP-1366 on safety, tolerability and pharmacokinetics of amoxicillin and clarithromycin in healthy subjects Read more about this study

Who is it for?
Ages 19 years and olderHealthy volunteers can take part
What is being tested?
JP-1366 20mg 1capsule, Amoxicillin 500Mg Cap and Clarithromycin 500Mg Tab
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
1 siteSouth Korea
Study dates
18 Nov 2020to 19 Jan 2021
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Subject who has fully informed about this study and understand completely, decide to participate voluntarily and agree with the written consent approved by the IRB in Bundang Cha hospital before screening test.
  • A healthy volunteer in the age of upper 19 at the time of the screening test.
  • Subject whose BMI was 18.0 or more and 30.0 or less and whose body weight was 50kg or more if in male, and 45kg or more if in female at the same time.
  • Body Mass Index (BMI) = Body weight(kg) / Height(m)2

Who cannot join

  • 1. Medical History
  • The Subject who has clinically significant diseases with liver, kidney, nervous system, digestive system, respiratory system, and endocrine system, musculoskeletal system or the blood or tumor disease, cardiovascular disease (including orthostatic hypotension), mental disorder or with history of the disease.
  • The subject who has a history of gastrointestinal disorders (gastrointestinal ulcers, gastritis, gastric ulcer, gastroesophageal reflux disease, Crohn's disease, etc.) or history of gastrointestinal surgery that may affect the safety and PK/PD Evaluation of the investigational product (Except for simple cecal surgery and hernia surgery)
  • The subject who has a hereditary disorder (galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption etc.).
  • 2. Allergy drug hypersensitivity and drug abuse
  • The subject with clinically significant hypersensitivity reactions (Except a slight allergic rhinitis which is no need to administration).
Show all 30Show fewer
  • The subject with the history of hypersensitivity reactions to the investigational product, the ingredients in investigational product (FCF, Sunset Yellow FCF), Digestive ulcer drugs and other drugs (aspirin, antibiotics, etc.)
  • The subject who has a history of drug abuse or who has tested positive for an abuse drug in a drug screening test.
  • 3. Laboratory Test
  • Vital Sign Measures of resting blood pressure while the subject remained in the sitting position for at least 3 minutes. Systolic > 150 mmHg or < 90 mmHg, or diastolic > 100 mmHg or < 50 mmHg.
  • Screening laboratory test showing any of the following abnormal laboratory results:
  • ALT, AST, Total bilirubin > 2.0 x ULN
  • e-GFR < 60 mL/min/1.73m2 (CKD-EPI formula)
  • Positive result for Serological test (HBsAg, HCV Ab, HIV Ab, Syphilis regain test)
  • Clinically significant ECG abnormalities
  • 4. Prohibited medication and therapy
  • The subject taking drug of enzyme induction or inhibition within one month prior to the first scheduled drug administration.
  • The subject who has participated in other clinical trials or bioequivalence studied and received and received clinical trial drug or bioequivalence study drug, within 6 months prior to the first scheduled drug administration.
  • The subject taking any prohibited drug or herbal medicine, OTC drugs or vitamin within 2 weeks prior to the first scheduled drug administration.
  • The subject who has taken any diet which affect to drug metabolism (Grapefruit juice, Broccoli, Garlic extract etc.) within 3 days prior to the first scheduled drug administration or who cannot be forbidden the ingestion of it.
  • 5. Donating and Receiving blood
  • The subject who did a whole blood donation within 2 months prior to the first scheduled drug administration or a component blood donation (pheresis) within one month
  • The subject who has received blood transfusions within one month prior to the first scheduled drug administration.
  • 6. Pregnant and Contraception
  • Pregnant and Lactating women
  • Subjects who do not agree to use medically acceptable methods of contraception during the period study - Use of an intrauterine device - Use of barrier contraception (for men or women) and using spermicidal at the same time - Vasectomy, tubectomy, tubal ligation, hysterectomy
  • 7. And others
  • Subjects who are judged unsuitable to participate in the study in the opinion of the investigator
  • The subject who continue to drink (over 21units/week, 1 unit = 10g of pure alcohol) within 6 months from screening or who cannot abstain from drinking during the clinical trial period from 3days before the first administration date.
  • The subject whose average smoking amount exceeds 10 cigarettes per day within 6 months.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Cha University Bundang Medical Center

    Gyeonggi-do

Other trials in South Korea

About this study

Official title: A Randomized, Open-label, Multiple-dose, 3-way Crossover Phase 1 Clinical Trial to Evaluate Drug-drug Interactions and Safety Among JP-1366, Amoxicillin, and Clarithromycin in Healthy Volunteers

To evaluate the effect of coadministration of amoxicillin and clarithromycin on safety, tolerability and pharmacokinetics of JP-1366 in healthy subjects and the effect of JP-1366 on safety, tolerability and pharmacokinetics of amoxicillin and clarithromycin in healthy subjects

Being tested
JP-1366 20mg 1capsule, Amoxicillin 500Mg Cap, Clarithromycin 500Mg Tab

What participants receive

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

  • JP-1366 20mg 1capsuleDrug

    will be orally administered

  • Amoxicillin 500Mg CapDrug

    Amoxicilin 500Mg 2 capsules will be orally administered

  • Clarithromycin 500Mg TabDrug

    Amoxicilin 500Mg 1 tablet will be orally administered

Study groups in NCT05194046
Study groupRoleWhat they receive
Sequence AExperimentalT1→Washout period(D6~14)→ T3→Washout period(D20~28)→ T2 * T1: JP-1366 1capsule, 2 times per 1 day, repetition administration for 5 days * T2: amoxicillin 500mg 2 capsules + clarithromycin 500mg 1 tablet, 2 times per 1 day, repetition administration for 5 days * T3: JP-1366 1 capsule + amoxicillin 500mg 2 capsules + clarithromycin 500mg 1 tablet, 2 times per 1 day, repetition administration for 5 days
Receives: Drug: JP-1366 20mg 1capsule; Drug: Amoxicillin 500Mg Cap; Drug: Clarithromycin 500Mg Tab
Sequence BExperimentalT1 →Washout period(D6~14)→ T2→Washout period(D20~28) → T3 * T1: JP-1366 1 capsule, 2 times per 1 day, repetition administration for 5 days * T2: amoxicillin 500mg 2 capsules + clarithromycin 500mg 1 tablet, 2 times per 1 day, repetition administration for 5 days * T3: JP-1366 1 capsule + amoxicillin 500mg 2 capsules + clarithromycin 500mg 1 tablet, 2 times per 1 day, repetition administration for 5 days
Receives: Drug: JP-1366 20mg 1capsule; Drug: Amoxicillin 500Mg Cap; Drug: Clarithromycin 500Mg Tab
Sequence CExperimentalT2 →Washout period(D6~14)→ T3→Washout period(D20~28) → T1 * T1: JP-1366 1capsule, 2 times per 1 day, repetition administration for 5 days * T2: amoxicillin 500mg 2 capsules + clarithromycin 500mg 1 tablet, 2 times per 1 day, repetition administration for 5 days * T3: JP-1366 1 capsule + amoxicillin 500mg 2 capsules + clarithromycin 500mg 1 tablet, 2 times per 1 day, repetition administration for 5 days
Receives: Drug: JP-1366 20mg 1capsule; Drug: Amoxicillin 500Mg Cap; Drug: Clarithromycin 500Mg Tab
Sequence DExperimentalT2 →Washout period(D6~14)→ T1→Washout period(D20~28) → T3 * T1: JP-1366 1 capsule, 2 times per 1 day, repetition administration for 5 days * T2: amoxicillin 500mg 2 capsules + clarithromycin 500mg 1 tablet, 2 times per 1 day, repetition administration for 5 days * T3: JP-1366 1 capsule + amoxicillin 500mg 2 capsules + clarithromycin 500mg 1 tablet, 2 times per 1 day, repetition administration for 5 days
Receives: Drug: JP-1366 20mg 1capsule; Drug: Amoxicillin 500Mg Cap; Drug: Clarithromycin 500Mg Tab
Sequence EExperimentalT3 →Washout period(D6~14)→ T1→Washout period(D20~28) → T2 * T1: JP-1366 1 capsule, 2 times per 1 day, repetition administration for 5 days * T2: amoxicillin 500mg 2 capsules + clarithromycin 500mg 1 tablet, 2 times per 1 day, repetition administration for 5 days * T3: JP-1366 1 capsule + amoxicillin 500mg 2 capsules + clarithromycin 500mg 1 tablet, 2 times per 1 day, repetition administration for 5 days
Receives: Drug: JP-1366 20mg 1capsule; Drug: Amoxicillin 500Mg Cap; Drug: Clarithromycin 500Mg Tab
Sequence FExperimentalT3 →Washout period(D6~14)→ T2→Washout period(D20~28) → T1 * T1: JP-1366 1 capsule, 2 times per 1 day, repetition administration for 5 days * T2: amoxicillin 500mg 2 capsules + clarithromycin 500mg 1 tablet, 2 times per 1 day, repetition administration for 5 days * T3: JP-1366 1 capsule + amoxicillin 500mg 2 capsules + clarithromycin 500mg 1 tablet, 2 times per 1 day, repetition administration for 5 days
Receives: Drug: JP-1366 20mg 1capsule; Drug: Amoxicillin 500Mg Cap; Drug: Clarithromycin 500Mg Tab

What is being measured

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

  1. Cmax,ss of JP-1366, Amoxicillin, Clarithromycin

    Measured: The time of steady state (after repetition administration for 5 days)

  2. AUCτ of JP-1366, Amoxicillin, Clarithromycin

    Measured: The time of steady state (after repetition administration for 5 days)

Secondary outcomes (7)

  1. Tmax of JP-1366, Amoxicillin, Clarithromycin, 14-OH-Clarithromycin

    Measured: The time of steady state (after repetition administration for 5 days)

  2. t1/2 of JP-1366, Amoxicillin, Clarithromycin, 14-OH-Clarithromycin

    Measured: The time of steady state (after repetition administration for 5 days)

  3. CLss/F of JP-1366, Amoxicillin, Clarithromycin, 14-OH-Clarithromycin

    Measured: The time of steady state (after repetition administration for 5 days)

  4. Vdss/F of JP-1366, Amoxicillin, Clarithromycin, 14-OH-Clarithromycin

    Measured: The time of steady state (after repetition administration for 5 days)

  5. Cmax,ss of 14-OH-Clarithromycin

    Measured: The time of steady state (after repetition administration for 5 days)

  6. AUCτ of 14-OH-Clarithromycin

    Measured: The time of steady state (after repetition administration for 5 days)

  7. 14-OH-Clarithromycin/Clarithromycin metabolic ratio

    Measured: The time of steady state (after repetition administration for 5 days)

Timeline

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

  1. First posted18 Jan 2022
  2. Study start18 Nov 2020
  3. Primary completion16 Jan 2021
  4. Study completion19 Jan 2021

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
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05194046
Sponsor's protocol ID
JP-1366-102
Status last verified
Jan 2022
First submitted
30 Nov 2021
Last updated
18 Jan 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JP-1366 20mg 1capsule, Amoxicillin 500Mg Cap and Clarithromycin 500Mg Tab in people with Helicobacter Pylori Associated Gastrointestinal Disease, run by Onconic Therapeutics Inc. 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 4 inclusion and 30 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 18 Jan 2022. 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?

Cmax,ss of JP-1366, Amoxicillin, Clarithromycin (time frame: The time of steady state (after repetition administration for 5 days)). The study lists 2 primary outcomes in all. 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 NCT05194046.

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 18 Jan 2022.

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