A Study of Vonoprazan in Adults With Helicobacter Pylori

Sponsor

Takeda (Industry)

Overall Status

Completed

CT.gov ID

NCT04753437

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

6.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Helicobacter Pylori (H Pylori) is a bug found in the digestive system. It can cause soreness and redness in the stomach (gastritis). It can also cause ulcers in the stomach and other parts of the digestive system. Vonoprazan is a medicine to treat people with H Pylori. It is taken together with other medicines to fight infections caused by H Pylori.

The main aim of this study is to learn if vonoprazan changes how the other medicines are processed by the body. It will be compared with another medicine called esomeprazole. Other aims are to check for side effects from the study medicines.

At the first visit, the study doctor will check who can take part. Participants who take part will be picked for 1 of 2 treatments by chance.

Vonoprazan taken with bismuth, clarithromycin, and amoxicillin
Esomeprazole taken with bismuth, clarithromycin, and amoxicillin

Both treatments will last for 14 days. Participants will stay in the clinic throughout their treatment.

After treatment, the clinic staff will telephone the participants 2 days later for a check-up. The participants will visit the clinic 4 weeks later for a final check-up.

Condition or Disease	Intervention/Treatment	Phase
Helicobacter Pylori	Drug: Clarithromycin Drug: Amoxicillin Drug: Bismuth potassium citrate Drug: Esomeprazole Drug: Vonoprazan	Phase 1

Detailed Description

This is a study in healthy participants with Helicobacter pylori (HP positive) to evaluate the safety, tolerability and PK of a quadruple therapy with bismuth, clarithromycin, amoxicillin, and vonoprazan versus quadruple therapy with bismuth, clarithromycin, amoxicillin, and esomeprazole.

The treatment phase consists of quadruple therapy twice daily (BID) with bismuth potassium citrate (600 mg), clarithromycin (500 mg), amoxicillin (1000 mg), and vonoprazan (20 mg) (Group B) or quadruple therapy BID with bismuth potassium citrate (600 mg), clarithromycin (500 mg), amoxicillin (1000 mg), and esomeprazole (20 mg) (Group A) from Days 1 to 14. Participants will be discharged on Day 15 after all procedures have been performed.

This single-center will be conducted in China. 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

A Phase 1, Double-Blind, Parallel Group Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Quadruple Therapy (Bismuth, Clarithromycin, and Amoxicillin) With Vonoprazan Versus Quadruple Therapy With Esomeprazole

Actual Study Start Date :

Apr 6, 2021

Actual Primary Completion Date :

Sep 27, 2021

Actual Study Completion Date :

Nov 5, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group A: Clarithromycin + Amoxicillin + Bismuth + Esomeprazole Clarithromycin 500 milligram (mg), tablets, orally, twice daily, along with amoxicillin 1000 mg, capsules, orally, twice daily, bismuth potassium citrate 600 mg, tablets, orally, twice daily, and esomeprazole 20 mg, capsules, orally, twice daily on Days 1 to 14.	Drug: Clarithromycin Clarithromycin tablets. Drug: Amoxicillin Amoxicillin capsules. Drug: Bismuth potassium citrate Bismuth potassium citrate tablets. Drug: Esomeprazole Esomeprazole tablets.
Experimental: Group B: Clarithromycin + Amoxicillin + Bismuth + Vonoprazan Clarithromycin 500 mg, tablets, orally, twice daily, along with amoxicillin 1000 mg, capsules, orally, twice daily, bismuth potassium citrate 600 mg, tablets, orally, twice daily, and vonoprazan 20 mg, tablets, orally, twice daily on Days 1 to 14.	Drug: Clarithromycin Clarithromycin tablets. Drug: Amoxicillin Amoxicillin capsules. Drug: Bismuth potassium citrate Bismuth potassium citrate tablets. Drug: Vonoprazan Vonoprazan tablets. Other Names: TAK-438

Arm

Intervention/Treatment

Active Comparator: Group A: Clarithromycin + Amoxicillin + Bismuth + Esomeprazole

Clarithromycin 500 milligram (mg), tablets, orally, twice daily, along with amoxicillin 1000 mg, capsules, orally, twice daily, bismuth potassium citrate 600 mg, tablets, orally, twice daily, and esomeprazole 20 mg, capsules, orally, twice daily on Days 1 to 14.

Drug: Clarithromycin

Clarithromycin tablets.

Drug: Amoxicillin

Amoxicillin capsules.

Drug: Bismuth potassium citrate

Bismuth potassium citrate tablets.

Drug: Esomeprazole

Esomeprazole tablets.

Experimental: Group B: Clarithromycin + Amoxicillin + Bismuth + Vonoprazan

Clarithromycin 500 mg, tablets, orally, twice daily, along with amoxicillin 1000 mg, capsules, orally, twice daily, bismuth potassium citrate 600 mg, tablets, orally, twice daily, and vonoprazan 20 mg, tablets, orally, twice daily on Days 1 to 14.

Drug: Clarithromycin

Clarithromycin tablets.

Drug: Amoxicillin

Amoxicillin capsules.

Drug: Bismuth potassium citrate

Bismuth potassium citrate tablets.

Drug: Vonoprazan

Vonoprazan tablets.

Other Names:

TAK-438

Outcome Measures

Primary Outcome Measures

Cmax: Maximum Observed Plasma Concentration for Bismuth [Day 14: pre-morning dose and at multiple time points (up to 12 hours) post-morning dose]
AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Time tau (τ) Over the Dosing Interval for Bismuth [Day 14: pre-morning dose and at multiple time points (up to 12 hours) post-morning dose]
Aeτ: Amount of Bismuth Excreted in Urine Over a Dosing Interval for Bismuth [Day 14: pre-morning dose and at multiple time points (up to 12 hours) post-morning dose]

Secondary Outcome Measures

Percentage of Participants who Experience at Least one Treatment Emergent Adverse Event (TEAE) [Baseline up to Day 17]
Percentage of Participants who Discontinue due to an Adverse Event (AE) [Baseline up to Day 17]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

HP positive participants.
Weighs at least 50 kilogram (kg) and has a body mass index between greater than (>) 18 and less than equal to (<=) 30 kilogram per square meter (kg/m^2), inclusive, at screening and Day -1 (check-in).
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:

Has a positive urine drug result for drugs of abuse at Screening or Check-in (Day -1).
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).
Has history of gastroesophageal reflux disease (GERD), symptomatic GERD, erosive esophagitis, duodenal ulcer, gastric ulcer, Barrett's esophagus, or Zollinger-Ellison syndrome, or has current or recent (within 6 months) gastrointestinal disease that would be expected to influence the absorption of drugs.
Has undergone therapeutic upper gastrointestinal endoscopic therapy (example, endoscopic hemostasis or excision including biopsy) within 30 days prior to Screening.
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).
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.
Has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody/antigen at Screening.
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.
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
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).
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.