Drug Interaction Study Between Tegoprazan, Bismuth, Amoxicillin and Clarithromycin

NCT05915871 | Completed Phase 1

• 1 other identifier: NE822202
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the pharmacokinetic interaction between tegoprazan and combination of Amoxicillin, Clarithromycin and bismuth in healthy adult volunteers.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• AUCtau of Tegoprazan, Bismuth, Amoxicillin, and Clarithromycin Following Multiple Oral Doses

  Area under the curve over a 12-hour dosing interval at steady state (AUCtau)

  Up to Day 27

• Cmax,ss of Tegoprazan, Bismuth, Amoxicillin, and Clarithromycin Following Multiple Oral Doses

  Steady state maximum concentration (Cmax,ss)

  Up to Day 27

Secondary Outcomes (13)

• Tmax,ss of tegoprazan, bismuth, amoxicillin, and clarithromycin

  Up to Day 27

• T1/2 of tegoprazan, bismuth, amoxicillin, and clarithromycin

  Up to Day 27

• CL/F of tegoprazan, bismuth, amoxicillin, and clarithromycin

  Up to Day 27

• Vdss/F of tegoprazan, bismuth, amoxicillin, and clarithromycin

  Up to Day 27

• Cmax,ss of M1 (tegoprazan metabolite) and 14-hydroxyclarithromycin

  Up to Day 27

Study Arms (1)

Tegoprazan, Bismuth, Amoxicillin and Clarithromycin

EXPERIMENTAL

Oral administration of Tegoprazan 50 mg twice daily on Days 1 to 7. Oral administration of Bismuth 600 mg twice daily, Amoxicilli 1000 mg twice daily and Clarithromycin 500 mg twice daily on Days 14 to 20. Oral administration of Tegoprazan 50 mg twice daily, Bismuth 600 mg twice daily, Amoxicilli 1000 mg twice daily and Clarithromycin 500mg twice daily on Days 21 to 27.

Drug: Tegoprazan; Drug: Bismuth; Drug: Amoxicilli; Drug: Clarithromycin

Interventions

Tegoprazan DRUG

Tablet for oral administration

Tegoprazan, Bismuth, Amoxicillin and Clarithromycin

Bismuth DRUG

Capsule for oral administration

Tegoprazan, Bismuth, Amoxicillin and Clarithromycin

Amoxicilli DRUG

Capsule for oral administration

Tegoprazan, Bismuth, Amoxicillin and Clarithromycin

Clarithromycin DRUG

Tablet for oral administration

Tegoprazan, Bismuth, Amoxicillin and Clarithromycin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. Subjects fully understand the objectives, nature, method, possible AEs of the trial, voluntarily participate in this clinical study, sign the ICF in person prior to the start of any study procedure, and promise that they will participate in all the study procedures in person.
• \. Chinese healthy male and non-lactating female subjects who are 18 to 55 years of age (inclusive) at the signing of ICF.
• \. Body mass index (BMI) of 19.0 to 28.0 kg/m2 (inclusive); and male weight ≥ 50.0 kg, female weight ≥ 45.0 kg.
• \. Subjects can communicate well with the investigator and understand and comply with various requirements of the study.

You may not qualify if:

• \. Diseases with prior and current abnormal clinical manifestations to be excluded, including but not limited to diseases of the nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism, and bones.
• \. People with a history of specific allergy (asthma, urticaria, eczema, etc.), an allergic constitution, or known hypersensitivity to tegoprazan, bismuth potassium citrate, amoxicillin, clarithromycin, penicillin, and macrolide antibiotics, or hypersensitivity to any ingredient of the drug products.
• \. Positive reaction to penicillin skin test. 4. History of active ulcer or significant hemorrhage from gastrointestinal tract, genitourinary tract or respiratory tract, or central nervous system hemorrhage.
• \. History of dysphagia or any gastrointestinal disorder affecting drug absorption (as judged by the investigator).
• \. Surgery within 3 months prior to screening, or planning to receive surgery during the study, and history of any surgery that may affect drug absorption (e.g., gastrectomy).
• \. Intolerance to venipuncture, or history of fear of needles or blood. 8. Lactose intolerance (history of diarrhea due to drinking milk). 9. History of illicit drug abuse within 6 months prior to screening, history of illicit drug use, or urine drug screen test positive.
• \. Mean alcohol use \> 14 units of alcohol (1 unit of alcohol ≈ 360 mL of beer, 150 mL of wine, or 45 mL of spirit) per week within 3 months prior to screening, or alcohol breath test positive, or inability to stop drinking during the trial period.
• \. Mean daily smoking \> 5 cigarettes within 3 months prior to screening, or inability to stop using any tobacco products during the trial period.
• \. Participation in any clinical trial of other investigational drug/device within 3 months prior to the first dose of study drug, or participation in 3 or more drug/device clinical trials in the past one year; if the half-life of other study drugs is long (5 half-lives exceed 3 months), the time interval required will be longer, i.e., 5 half-lives of the drug.
• \. Blood donation including donating blood components or massive blood loss (≥ 200 mL) within 3 months prior to screening; blood transfusion or use of blood products within 3 months prior to screening.
• \. History of vaccination within 1 month prior to screening, or planned vaccination during the study period.
• \. Use of any drugs inhibiting or inducing hepatic drug metabolism within 28 days prior to first dose of study drug.
• \. Use of any prescription drugs, over-the-counter drugs, dietary supplements, or Chinese herbal medicines within 14 days prior to first dose.
• \. Any of the hepatitis B surface antigen, hepatitis C virus antibody, anti-human immunodeficiency virus antibody, or anti-Treponema pallidum specific antibody tests is positive.
• \. At the time of screening, the results of vital signs (blood pressure, pulse rate, and body temperature), physical examination, and laboratory tests (complete blood count, blood chemistry, coagulation, and urinalysis) are judged as abnormal and clinically significant by the investigator.

Sponsors & Collaborators

• Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.: lead

Study Sites (1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

Location

MeSH Terms

Interventions

tegoprazan; Bismuth; Clarithromycin

Intervention Hierarchy (Ancestors)

Elements, Radioactive; Elements; Inorganic Chemicals; Metals, Heavy; Radioisotopes; Isotopes; Metals; Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2023
• First Posted: June 23, 2023
• Study Start: March 23, 2023
• Primary Completion: April 28, 2023
• Study Completion: April 28, 2023
• Last Updated: June 23, 2023

Record last verified: 2023-06

Locations

CN (1)