Phase 1
N=44
A Study of Vonoprazan in Adults With Helicobacter Pylori
Helicobacter Pylori
Bottom Line
View on ClinicalTrials.gov: NCT04753437 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcome: Primary: Cmax: Maximum Observed Plasma Concentration for Bismuth — 42.8; 32.9 nanogram per milliliter (ng/mL)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Clarithromycin (Drug); Amoxicillin (Drug); Bismuth potassium citrate (Drug); Esomeprazole (Drug); Vonoprazan (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax: Maximum Observed Plasma Concentration for Bismuth |
42.8; 32.9 | — |
| PRIMARY AUCτ: Area Under the Plasma Concentration-time Curve During a Dosing Interval τ for Bismuth |
146; 137 | — |
| PRIMARY Aeτ: Total Amount of Bismuth Excreted in Urine During a Dosing Interval τ for Bismuth |
1026; 1037 | — |
| SECONDARY Percentage of Participants Who Experience at Least One Treatment-Emergent Adverse Event (TEAE) |
95.5; 95.5 | — |
| SECONDARY Percentage of Participants Who Discontinued Study Drug Due to a Treatment-Emergent Adverse Event (TEAE) |
9.1; 22.7 | — |
Summary
Helicobacter Pylori (H Pylori) is a bug found in the digestive system. It can cause soreness and redness in the stomach (gastritis). It can also cause ulcers in the stomach and other parts of the digestive system. Vonoprazan is a medicine to treat people with H Pylori. It is taken together with other medicines to fight infections caused by H Pylori.
The main aim of this study is to learn if vonoprazan changes how the other medicines are processed by the body. It will be compared with another medicine called esomeprazole. Other aims are to check for side effects from the study medicines.
At the first visit, the study doctor will check who can take part. Participants who take part will be picked for 1 of 2 treatments by chance.
* Vonoprazan taken with bismuth, clarithromycin, and amoxicillin
* Esomeprazole taken with bismuth, clarithromycin, and amoxicillin
Both treatments will last for 14 days. Participants will stay in the clinic throughout their treatment.
After treatment, the clinic staff will telephone the participants 2 days later for a check-up. The participants will visit the clinic 4 weeks later for a final check-up.
Eligibility Criteria
Inclusion Criteria
- HP positive participants.
- Weighs at least 50 kilogram (kg) and has a body mass index between greater than (>) 18 and less than equal to ( the upper limit of normal (ULN).
- Has reduced renal function assessed by having an estimated glomerular filtration rate <90 milliliter per min per 1.73 square meter (mL/min/1.73 m^2) (as estimated by Chronic Kidney Disease-Epidemology Collaboration) at Screening or Check-in.
Data sourced from ClinicalTrials.gov (NCT04753437). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.