NCT02892409

TAK-438 Bismuth Drug Interaction Study

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 19 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

• Helicobacter Pylori

Interventions

Type	Name	Description
DRUG	Clarithromycin	Clarithromycin tablets
DRUG	Amoxicillin	Amoxicillin capsules
DRUG	Tripotassium bismuth dicitrate	Tripotassium bismuth dicitrate tablets
DRUG	Lansoprazole	Lansoprazole capsules
DRUG	TAK-438	TAK-438 tablets

Timeline

• Start date: 2016-09-05
• Primary completion: 2017-04-17
• Completion: 2017-05-11
• First posted: 2016-09-08
• Last updated: 2019-01-03
• Results posted: 2019-01-03

Locations

1 site across 1 country: South Korea