Approval Probability
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Adjusted LOA
ML Risk
Tripotassium bismuth dicitrate · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Clarithromycin + Amoxicillin + Bismuth + Lansoprazole | ACTIVE_COMPARATOR | Clarithromycin 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-438 | EXPERIMENTAL | Clarithromycin 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. |
| Name | Type | Description |
|---|---|---|
| Clarithromycin | DRUG | Clarithromycin tablets |
| Amoxicillin | DRUG | Amoxicillin capsules |
| Tripotassium bismuth dicitrate | DRUG | Tripotassium bismuth dicitrate tablets |
| Lansoprazole | DRUG | Lansoprazole capsules |
| TAK-438 | DRUG | TAK-438 tablets |
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...
Tripotassium bismuth dicitrate is a small molecule therapeutic being developed by Takeda Pharmaceutical Company Limited for Helicobacter pylori infection, a gastrointestinal condition. It is currently in Phase 1 clinical development. Bismuth-containing compounds are used in gastrointestinal medicine, and this candidate is being studied in a drug interaction trial.
Tripotassium bismuth dicitrate is being studied for Helicobacter pylori, a bacterial infection of the stomach and gastrointestinal tract. It is in Phase 1 development, so it is investigational and not yet established as a treatment. Its only recorded trial enrolled 30 participants with Helicobacter pylori in South Korea.
Tripotassium bismuth dicitrate is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor of the Phase 1 trial studying the drug. The company is a global pharmaceutical manufacturer with a portfolio that includes gastrointestinal medicines.
Tripotassium bismuth dicitrate is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. One Phase 1 trial has been completed, and no trials are currently active. The completed study was a randomized, double-blind, active-controlled drug interaction study.
Tripotassium bismuth dicitrate has been studied in one completed Phase 1 trial, NCT02892409, titled TAK-438 Bismuth Drug Interaction Study. It enrolled 30 participants with Helicobacter pylori in South Korea. The trial was randomized, double-blind, and active-controlled, and included participants aged 19 years and older of all sexes.