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Tripotassium bismuth dicitrate

Phase 1

Helicobacter Pylori | Small molecule | Gastrointestinal |Takeda Pharmaceutical Company Limited|Last Updated: Jan 3, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

Tripotassium bismuth dicitrate · 1 trial · 1 indication

Phase 1 1
NCT02892409TAK-438 Bismuth Drug Interaction StudyHelicobacter Pylori
COMPLETED30 Analytics
PHASE1COMPLETED
TAK-438 Bismuth Drug Interaction Study
Helicobacter Pylori
NCT0289240930
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Study Endpoints

Primary Endpoints

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
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post-dose
Baseline up Day 15
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose
Baseline up to Day 15
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose
Baseline up to Day 15
Cmax: Maximum Observed Plasma Concentration for Bismuth
Day 14 pre-dose and at multiple timepoints (up to 12 hours) post-dose
AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for Bismuth
Day 14 pre-dose and at multiple timepoints (up to 12 hours) post-dose
Aeτ: Amount of Drug Excreted in Urine During a Dosing Interval for Bismuth
Day 14 pre-dose and at multiple timepoints (up to 12 hours) post-dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Clarithromycin + Amoxicillin + Bismuth + LansoprazoleACTIVE_COMPARATORClarithromycin 500 milligram (mg), tablets, orally, twice daily, along with amoxicillin 1000 mg capsules, orally, twice daily, tripotassium bismuth dicitrate 600 mg, tablets, orally, twice daily, and lansoprazole 30 mg, capsules, orally, twice daily on Days 1 to 14.
Clarithromycin + Amoxicillin + Bismuth + TAK-438EXPERIMENTALClarithromycin 500 mg, tablets, orally, twice daily, along with amoxicillin 1000 mg, capsules, orally, twice daily, tripotassium bismuth dicitrate 600 mg, tablets, orally, twice daily, and TAK-438 20 mg, tablets, orally, twice daily on Days 1 to 14.

Interventions

NameTypeDescription
ClarithromycinDRUGClarithromycin tablets
AmoxicillinDRUGAmoxicillin capsules
Tripotassium bismuth dicitrateDRUGTripotassium bismuth dicitrate tablets
LansoprazoleDRUGLansoprazole capsules
TAK-438DRUGTAK-438 tablets
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Eligibility Criteria

Age Range19 Years to 60 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. HP positive participants. 2. Has body mass index between greater than (\>) 18 and less than equal to (\<=) 30 kilogram per square meter (kg/m\^2) and weighs greater than equal to (\>=) 50 kilogram (kg). 3. Is willing to abstain from strenuous exercise from 72 hours before fir...

Countries:South Korea
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