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

NCT05194046 | Completed Phase 1

• 1 other identifier: JP-1366-102
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Helicobacter Pylori Associated Gastrointestinal Disease

Outcome Measures

Primary Outcomes (2)

• Cmax,ss of JP-1366, Amoxicillin, Clarithromycin

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

• AUCτ of JP-1366, Amoxicillin, Clarithromycin

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

Secondary Outcomes (7)

• Tmax of JP-1366, Amoxicillin, Clarithromycin, 14-OH-Clarithromycin

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

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

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

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

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

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

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

• Cmax,ss of 14-OH-Clarithromycin

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

Other Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  Through study completion, an average of 46 days

Study Arms (6)

Sequence A

EXPERIMENTAL

T1→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

Drug: JP-1366 20mg 1capsule; Drug: Amoxicillin 500Mg Cap; Drug: Clarithromycin 500Mg Tab

Sequence B

EXPERIMENTAL

T1 →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

Drug: JP-1366 20mg 1capsule; Drug: Amoxicillin 500Mg Cap; Drug: Clarithromycin 500Mg Tab

Sequence C

EXPERIMENTAL

T2 →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

Drug: JP-1366 20mg 1capsule; Drug: Amoxicillin 500Mg Cap; Drug: Clarithromycin 500Mg Tab

Sequence D

EXPERIMENTAL

T2 →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

Drug: JP-1366 20mg 1capsule; Drug: Amoxicillin 500Mg Cap; Drug: Clarithromycin 500Mg Tab

Sequence E

EXPERIMENTAL

T3 →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

Drug: JP-1366 20mg 1capsule; Drug: Amoxicillin 500Mg Cap; Drug: Clarithromycin 500Mg Tab

Sequence F

EXPERIMENTAL

T3 →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

Drug: JP-1366 20mg 1capsule; Drug: Amoxicillin 500Mg Cap; Drug: Clarithromycin 500Mg Tab

Interventions

JP-1366 20mg 1capsule DRUG

will be orally administered

Sequence A; Sequence B; Sequence C; Sequence D; Sequence E; Sequence F

Amoxicillin 500Mg Cap DRUG

Amoxicilin 500Mg 2 capsules will be orally administered

Sequence A; Sequence B; Sequence C; Sequence D; Sequence E; Sequence F

Clarithromycin 500Mg Tab DRUG

Amoxicilin 500Mg 1 tablet will be orally administered

Sequence A; Sequence B; Sequence C; Sequence D; Sequence E; Sequence F

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \. 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.).
• \. Allergy drug hypersensitivity and drug abuse
• The subject with clinically significant hypersensitivity reactions (Except a slight allergic rhinitis which is no need to administration).
• 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.
• \. 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

Sponsors & Collaborators

• Onconic Therapeutics Inc.: lead

Study Sites (1)

Cha University Bundang Medical Center

Gyeonggi-do, South Korea

Location

MeSH Terms

Interventions

Amoxicillin; Capsules; Clarithromycin

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations; Erythromycin; Macrolides; Polyketides; Lactones

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: November 30, 2021
• First Posted: January 18, 2022
• Study Start: November 18, 2020
• Primary Completion: January 16, 2021
• Study Completion: January 19, 2021
• Last Updated: January 18, 2022

Record last verified: 2022-01

Locations

KR (1)