Evaluate the PK of Multiple Oral Doses of Tegoprazan, Metronidazole, Tetracycline and Bismuth in Healthy Volunteers

NCT04066257 | Completed Phase 1

• 1 other identifier: CJ_APA_111
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the pharmacokinetic interaction between tegoprazan and combination of metronidazole, tetracycline and bismuth in healthy adult volunteers.

Conditions

Healthy

Keywords

Drug-Drug interaction; pharmacokinetic

Outcome Measures

Primary Outcomes (4)

• AUC0-12 of tegaprazan and metabolite M1

  Area under the plasma concentration versus time curve of tegoprazan

  pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in period1 ,2.

• Cmax of tegaprazan and metabolite M1

  Peak Plasma Concentration of tegoprazan and metabolite M1

  pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in period1 ,2.

• AUC0-6 of metronidazole, tetracycline and bismuth

  Area under the plasma concentration versus time curve of metronidazole, tetracycline and bismuth

  pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in period1 ,2.

• Cmax of metronidazole, tetracycline and bismuth

  Peak Plasma Concentration of metronidazole, tetracycline and bismuth

  pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in period1 ,2.

Study Arms (3)

Tegoprazan 50 mg

ACTIVE COMPARATOR

Oral administration of Tegoprazan 50 mg twice daily for 7 days

Drug: Tegoprazan

Tegoprazan 50 mg+MTN 500 mg+TCL 500 mg+BIS 300 mg

ACTIVE COMPARATOR

Oral administration of Tegoprazan 50 mg twice daily, Metronidazole 500 mg three times daily, and Tetracycline hydrochloride 500 mg \& Tripotassium bismuth dicitrate 300 mg four times daily for 7 days

Drug: Tegoprazan; Drug: Metronidazole; Drug: Tetracycline; Drug: Bismuth

MTN 500 mg+TCL 500 mg+BIS 300 mg

ACTIVE COMPARATOR

Oral administration of Metronidazole 500 mg twice daily, Tetracycline hydrochloride 500 mg \& Tripotassium bismuth dicitrate 300 mg four times daily for 7 days

Drug: Metronidazole; Drug: Tetracycline; Drug: Bismuth

Interventions

Tegoprazan DRUG

Tegoprazan 50 mg tablet

Also known as: K-CAB

Tegoprazan 50 mg; Tegoprazan 50 mg+MTN 500 mg+TCL 500 mg+BIS 300 mg

Metronidazole DRUG

Metronidazole 250 mg tablet

Also known as: Flasinyl

MTN 500 mg+TCL 500 mg+BIS 300 mg; Tegoprazan 50 mg+MTN 500 mg+TCL 500 mg+BIS 300 mg

Tetracycline DRUG

Tetracycline hydrochloride 250 mg capsule

Also known as: Teracyclin

MTN 500 mg+TCL 500 mg+BIS 300 mg; Tegoprazan 50 mg+MTN 500 mg+TCL 500 mg+BIS 300 mg

Bismuth DRUG

Tripotassium bismuth dicitrate 300 mg tablet

Also known as: Denol

MTN 500 mg+TCL 500 mg+BIS 300 mg; Tegoprazan 50 mg+MTN 500 mg+TCL 500 mg+BIS 300 mg

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult aged ≥ 19 and \< 55 year-old on the day of obtaining the informed consent.
• Body mass index (BMI) ≥ 17.5 kg/m2 and \< 28.0 kg/m2 with a body weight ≥ 55 kg at screening.
• H. pylori negative.

You may not qualify if:

• Medical History
• History or evidence of clinically significant disease
• History of gastrointestinal disease (e.g., esophageal disease such as esophageal achalasia or stenosis, and Crohn's disease) or surgery that may affect the absorption of a drug.
• History or presence of hypersensitivity to IMPs, components of IMPs, benzimidazoles, imidazole derivatives or tetracycline antibiotics
• Laboratory tests(in blood)
• \) Total bilirubin, AST (GOT), ALT (GPT) \> 1.5 X upper limit of normal (ULN) at screening
• History of drug/alcohol abuse
• Participated in other study and received investigational product within 3 months prior to the first study dose.
• taken a medication known to substantially induce or inhibit a drug metabolizing enzyme
• Not able to use a medically acceptable contraceptive method throughout the study.

Sponsors & Collaborators

• HK inno.N Corporation: lead

Study Sites (1)

Chonbuk National University Hospital

Jeonju, South Korea

Location

Related Publications (1)

• Jeon JY, Kim SY, Moon SJ, Oh K, Lee J, Kim B, Song GS, Kim MG. Pharmacokinetic Interactions between Tegoprazan and Metronidazole/Tetracycline/Bismuth and Safety Assessment in Healthy Korean Male Subjects. Clin Ther. 2021 Apr;43(4):722-734. doi: 10.1016/j.clinthera.2021.01.026. Epub 2021 Feb 23.

  PMID: 33637332 DERIVED

MeSH Terms

Interventions

tegoprazan; Metronidazole; Tetracycline; Bismuth; bismuth tripotassium dicitrate

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Elements, Radioactive; Elements; Inorganic Chemicals; Metals, Heavy; Radioisotopes; Isotopes; Metals

Study Officials

• Min-Gul Kim, MD

  Chonbuk university hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 20, 2019
• First Posted: August 26, 2019
• Study Start: January 17, 2019
• Primary Completion: February 22, 2019
• Study Completion: April 25, 2019
• Last Updated: August 28, 2019

Record last verified: 2019-08

Locations

KR (1)