drugset / Trial / NCT02892409

TAK-438 Bismuth Drug Interaction Study

NCT02892409

Phase 1 Completed 30 enrolled Takeda
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2016-09-05
Primary completion
2017-04-17
Completion
2017-05-11

Drugs

EvaluationDrugModalityDoseRoute
Comparator Lansoprazole Other / unclassified 30 mg Oral
Subject Vonoprazan Other / unclassified 20 mg Oral
Background Amoxicillin Other / unclassified 1000 mg Oral
Background Clarithromycin Small molecule 500 mg Oral
Background Tripotassium bismuth dicitrate Unknown 600 mg Oral