Helicobacter Pylori Clinical Trial
Official title:
A Phase 1, Double-Blind, Parallel Group Study to Evaluate the Safety and Pharmacokinetics of Quadruple Therapy (Bismuth, Clarithromycin, and Amoxicillin) With TAK-438 Versus Quadruple Therapy With Lansoprazole
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.
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.
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