NCT04753437

A Study of Vonoprazan in Adults With Helicobacter Pylori

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Helicobacter Pylori

Interventions

Type	Name	Description
DRUG	Clarithromycin	Clarithromycin tablets.
DRUG	Amoxicillin	Amoxicillin capsules.
DRUG	Bismuth potassium citrate	Bismuth potassium citrate tablets.
DRUG	Esomeprazole	Esomeprazole tablets.
DRUG	Vonoprazan	Vonoprazan tablets.

Timeline

• Start date: 2021-04-06
• Primary completion: 2021-09-27
• Completion: 2021-11-05
• First posted: 2021-02-15
• Last updated: 2023-08-31
• Results posted: 2023-08-31

Locations

1 site across 1 country: China