Clinical trial NCT04066257: Evaluate the PK of Multiple Oral Doses of Tegoprazan, Metronidazole, Tetracycline and Bismuth in Healthy Volunteers
Official title: An Open-Label, Randomized, Crossover Study to Evaluate the Pharmacokinetic Interaction After Multiple Oral Doses of Tegoprazan, Metronidazole, Tetracycline and Bismuth in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Drug-Drug interaction
pharmacokinetic
Lead sponsor: HK inno.N Corporation
Sponsor class: INDUSTRY
First posted: 2019-08-26
Enrollment: 32
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

Detailed description: A open-label, randomized, multiple dose, two arm, two period, crossover study

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Medical History

  1. History or evidence of clinically significant disease
  2. 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.
  3. History or presence of hypersensitivity to IMPs, components of IMPs, benzimidazoles, imidazole derivatives or tetracycline antibiotics
* Laboratory tests(in blood)

  1) 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.

Primary outcomes:
measure: AUC0-12 of tegaprazan and metabolite M1
timeFrame: pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in period1 ,2.
measure: Cmax of tegaprazan and metabolite M1
timeFrame: pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in period1 ,2.
measure: AUC0-6 of metronidazole, tetracycline and bismuth
timeFrame: pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in period1 ,2.
measure: Cmax of metronidazole, tetracycline and bismuth
timeFrame: pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in period1 ,2.
Secondary outcomes:
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
Study officials:
affiliation: Chonbuk university hospital
name: Min-Gul Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.