TAK-438 Bismuth Drug Interaction Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-05

Study Completion Date

2017-05-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To evaluate the safety, tolerability, and pharmacokinetics (PK) of quadruple therapy with bismuth, clarithromycin, amoxicillin, and TAK-438 versus quadruple therapy with bismuth, clarithromycin, amoxicillin, and lansoprazole.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Evaluate the Efficacy and Safety of Bismuth-Containing Quadruple Therapy With Oral Vonoprazan (TAK-438) 20 mg Compared to Esomeprazole 20 mg Twice Daily in Paticipants With Helicobacter Pylori Infection

NCT04198363

Helicobacter Pylori

COMPLETED PHASE3

Efficacy of TAK-438, Amoxicillin and Clarithromycin in the First Line Eradication of H. Pylori

NCT01505127

H. Pylori Infection

COMPLETED PHASE3

Efficacy and Safety of Rifasutenizol (TNP 2198), Rabeprazole and Amoxicillin in Participants With H. Pylori Infection

NCT05857163

H.Pylori Infection

COMPLETED PHASE3

Efficacies of HDDT With or Without Bismuth vs Amoxicillin-metronidazole BQT for First-line H Pylori Eradication

NCT03897244

Helicobacter Pylori Infection

COMPLETED PHASE4

Efficacy of High-dose Dual Therapy vs Bismuth-containing Quadruple Therapy for Rescue Treatment of Hp Infection

NCT02490839

Helicobacter Pylori Infection

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a phase 1, double-blind, parallel group study in participants with Helicobacter pylori (HP positive) who are, additionally, cytochrome P-450 (CYP)2C19 extensive metabolizers (EM) to evaluate the safety, tolerability and pharmacokinetics (PK) of a quadruple therapy with bismuth, clarithromycin, amoxicillin, and TAK-438 versus quadruple therapy with bismuth, clarithromycin, amoxicillin, and lansoprazole. The study will enroll 30 participants.

The treatment phase consists of quadruple therapy twice daily (BID) with tripotassium bismuth dicitrate (600 mg), clarithromycin (500 mg), amoxicillin (1000 mg), and TAK-438 (20 mg) (Group B) or quadruple therapy BID with tripotassium bismuth dicitrate (600 mg), clarithromycin (500 mg), amoxicillin (1000 mg),and lansoprazole (30 mg) (Group A) from Days 1 to 14. Participants will be discharged on Day 15 after final PK blood samples are collected and all procedures performed.

This single-center will be conducted in Korea. Participants will remain confined to the study site from check-in (Day -1) through Day 15 and will followed up through call on Day 17 and return on Day 42 for a follow-up assessment.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Helicobacter Pylori

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Clarithromycin + Amoxicillin + Bismuth + Lansoprazole

Clarithromycin 500 milligram (mg), tablets, orally, twice daily, along with amoxicillin 1000 mg capsules, orally, twice daily, tripotassium bismuth dicitrate 600 mg, tablets, orally, twice daily, and lansoprazole 30 mg, capsules, orally, twice daily on Days 1 to 14.

Group Type ACTIVE_COMPARATOR

Clarithromycin

Intervention Type DRUG

Clarithromycin tablets

Amoxicillin

Intervention Type DRUG

Amoxicillin capsules

Tripotassium bismuth dicitrate

Intervention Type DRUG

Tripotassium bismuth dicitrate tablets

Lansoprazole

Intervention Type DRUG

Lansoprazole capsules

Clarithromycin + Amoxicillin + Bismuth + TAK-438

Clarithromycin 500 mg, tablets, orally, twice daily, along with amoxicillin 1000 mg, capsules, orally, twice daily, tripotassium bismuth dicitrate 600 mg, tablets, orally, twice daily, and TAK-438 20 mg, tablets, orally, twice daily on Days 1 to 14.

Group Type EXPERIMENTAL

Clarithromycin

Intervention Type DRUG

Clarithromycin tablets

Amoxicillin

Intervention Type DRUG

Amoxicillin capsules

Tripotassium bismuth dicitrate

Intervention Type DRUG

Tripotassium bismuth dicitrate tablets

TAK-438

Intervention Type DRUG

TAK-438 tablets

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Clarithromycin

Clarithromycin tablets

Intervention Type DRUG

Amoxicillin

Amoxicillin capsules

Intervention Type DRUG

Tripotassium bismuth dicitrate

Tripotassium bismuth dicitrate tablets

Intervention Type DRUG

Lansoprazole

Lansoprazole capsules

Intervention Type DRUG

TAK-438

TAK-438 tablets

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. HP positive participants.
2. Has body mass index between greater than (\>) 18 and less than equal to (\<=) 30 kilogram per square meter (kg/m\^2) and weighs greater than equal to (\>=) 50 kilogram (kg).
3. Is willing to abstain from strenuous exercise from 72 hours before first dose (Day 1) until the Follow-up call on Day 17.

Exclusion Criteria

1. Has a positive urine drug result for drugs of abuse at Screening or Check-in (Day -1).
2. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse (defined as regular consumption of 21 units or more units per week) at any time prior to the Screening Visit or is unwilling to agree to abstain from alcohol and drugs throughout the study (up to Day 17).
3. Has history of gastroesophageal reflux disease (GERD), symptomatic GERD, erosive esophagitis, duodenal ulcer, gastric ulcer, Barrett's esophagus, or Zollinger-Ellison syndrome.
4. Has undergone therapeutic upper gastrointestinal endoscopic therapy (example, endoscopic hemostasis or excision including biopsy) within 30 days prior to Screening.
5. Has undergone major surgical procedures within the past 1 month or are scheduled to undergo surgical procedures that may affect gastric acid secretion (example, abdominal surgery, vagotomy, or craniotomy).
6. Has a history of cancer, except basal cell carcinoma or Stage 1 squamous cell carcinoma of the skin that has been in remission for at least 5 years prior to Day 1.
7. Has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody/antigen at Screening.
8. Has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 6 weeks prior to Check-in. Cotinine test is positive at Screening or Check-in.
9. Has poor peripheral venous access. Has donated or lost 450 milliliter (mL) or more of his blood volume (including plasmapheresis), or had a transfusion of any blood product within 90 days prior to Day 1.
10. Has abnormal Screening or Check-in laboratory values that suggest a clinically significant underlying disease or subject with the following laboratory abnormalities: alanine aminotransferase (ALT), aspartate aminotransferase (AST) or total bilirubin \> the upper limit of normal (ULN).
11. Has reduced renal function assessed by having an estimated glomerular filtration rate \<90 milliliter per min per 1.73 square meter (mL/min/1.73 m\^2) (as estimated by Chronic Kidney Disease-Epidemology Collaboration) at Screening or Check-in.

Minimum Eligible Age

19 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No