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Clarithromycin

Phase 1

Helicobacter Pylori | Small molecule | Other |Takeda Pharmaceutical Company Limited|Last Updated: Aug 31, 2023

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials2
Total Enrollment74
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04753437A Study of Vonoprazan in Adults With Helicobacter PyloriPHASE1 COMPLETED 44 — — Apr 6, 2021Nov 5, 2021Aug 31, 20231 China
NCT02892409TAK-438 Bismuth Drug Interaction StudyPHASE1 COMPLETED 30 — — Sep 5, 2016May 11, 2017Jan 3, 20191 South Korea
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Study Endpoints
Primary Endpoints
Cmax: Maximum Observed Plasma Concentration for Bismuth
Day 14: 0 to 12 hours after the morning dose
AUCτ: Area Under the Plasma Concentration-time Curve During a Dosing Interval τ for Bismuth
Day 14: 0 to 12 hours after the morning dose
Aeτ: Total Amount of Bismuth Excreted in Urine During a Dosing Interval τ for Bismuth
Day 14: 0 to 12 hours after the morning dose
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
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
Secondary Endpoints
Percentage of Participants Who Experience at Least One Treatment-Emergent Adverse Event (TEAE)
From the first dose of study drug up to Day 17
Percentage of Participants Who Discontinued Study Drug Due to a Treatment-Emergent Adverse Event (TEAE)
From the first dose of study drug up to Day 17
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeOTHER
Treatment Arms
ArmTypeDescription
Clarithromycin + Amoxicillin + Bismuth + VonoprazanEXPERIMENTALClarithromycin 500 milligram (mg), tablets, orally, BID, along with amoxicillin 1000 mg, capsules, orally, BID, bismuth potassium citrate 600 mg, capsules, orally, BID, and vonoprazan 20 mg, tablets, orally, BID on Days 1 to 14.
Clarithromycin + Amoxicillin + Bismuth + EsomeprazoleACTIVE_COMPARATORClarithromycin 500 mg, tablets, orally, BID, along with amoxicillin 1000 mg, capsules, orally, BID, bismuth potassium citrate 600 mg, capsules, orally, BID, and esomeprazole 20 mg, tablets, orally, BID on Days 1 to 14.
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.
Bismuth potassium citrateDRUGBismuth potassium citrate tablets.
EsomeprazoleDRUGEsomeprazole tablets.
VonoprazanDRUGVonoprazan tablets.
Tripotassium bismuth dicitrateDRUGTripotassium bismuth dicitrate tablets
LansoprazoleDRUGLansoprazole capsules
TAK-438DRUGTAK-438 tablets
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. HP positive participants. 2. Weighs at least 50 kilogram (kg) and has a body mass index between greater than (\>) 18 and less than equal to (\<=) 30 kilogram per square meter (kg/m\^2), inclusive, at screening and Day -1 (check-in). 3. Is willing to abstain from strenuous exe...

Countries:ChinaSouth Korea
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