A Study of Vonoprazan in Adults With Helicobacter Pylori

Helicobacter Pylori Clinical Trial

Official title:

A Phase 1, Double-Blind, Parallel Group Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Quadruple Therapy (Bismuth, Clarithromycin, and Amoxicillin) With Vonoprazan Versus Quadruple Therapy With Esomeprazole

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04753437
• Other study ID #: Vonoprazan-1001
• Secondary ID: U1111-1257-0258
• Status: Completed
• Phase: Phase 1
• Start date: April 6, 2021
• Est. completion date: November 5, 2021

Study information

• Verified date: October 2022
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a study in healthy participants with Helicobacter pylori (HP positive) to evaluate the safety, tolerability and PK of a quadruple therapy with bismuth, clarithromycin, amoxicillin, and vonoprazan versus quadruple therapy with bismuth, clarithromycin, amoxicillin, and esomeprazole.

The treatment phase consists of quadruple therapy twice daily (BID) with bismuth potassium citrate (600 mg), clarithromycin (500 mg), amoxicillin (1000 mg), and vonoprazan (20 mg) (Group B) or quadruple therapy BID with bismuth potassium citrate (600 mg), clarithromycin (500 mg), amoxicillin (1000 mg), and esomeprazole (20 mg) (Group A) from Days 1 to 14. Participants will be discharged on Day 15 after all procedures have been performed.

This single-center will be conducted in China. Participants will remain confined to the study site from check-in (Day -1) through Day 15 and will followed up through call on Day 17 and return on Day 42 for a follow-up assessment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: November 5, 2021
• Est. primary completion date: September 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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 exercise from 72 hours before first dose (Day 1) until the Follow-up call on Day 17.

Exclusion Criteria:

1. Has a positive urine drug result for drugs of abuse at Screening or Check-in (Day -1).

2. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse (defined as regular consumption of 21 units or more units per week) at any time prior to the Screening Visit or is unwilling to agree to abstain from alcohol and drugs throughout the study (up to Day 17).

3. Has history of gastroesophageal reflux disease (GERD), symptomatic GERD, erosive esophagitis, duodenal ulcer, gastric ulcer, Barrett's esophagus, or Zollinger-Ellison syndrome, or has current or recent (within 6 months) gastrointestinal disease that would be expected to influence the absorption of drugs.

4. Has undergone therapeutic upper gastrointestinal endoscopic therapy (example, endoscopic hemostasis or excision including biopsy) within 30 days prior to Screening.

5. Has undergone major surgical procedures within the past 1 month or are scheduled to undergo surgical procedures that may affect gastric acid secretion (example, abdominal surgery, vagotomy, or craniotomy).

6. Has a history of cancer, except basal cell carcinoma or Stage 1 squamous cell carcinoma of the skin that has been in remission for at least 5 years prior to Day 1.

7. Has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody/antigen at Screening.

8. Has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 6 weeks prior to Check-in. Cotinine test is positive at Screening or Check-in.

9. Has poor peripheral venous access.

10. Has donated or lost 450 milliliter (mL) or more of his blood volume (including plasmapheresis), or had a transfusion of any blood product within 90 days prior to Day 1.

11. Has abnormal Screening or Check-in laboratory values that suggest a clinically significant underlying disease or subject with the following laboratory abnormalities: alanine aminotransferase (ALT), aspartate aminotransferase (AST) or total bilirubin > the upper limit of normal (ULN).

12. 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.

Related Conditions & MeSH terms

• Helicobacter Pylori

Intervention

Drug:
• Clarithromycin
Clarithromycin tablets.
• Amoxicillin
Amoxicillin capsules.
• Bismuth potassium citrate
Bismuth potassium citrate tablets.
• Esomeprazole
Esomeprazole tablets.
• Vonoprazan
Vonoprazan tablets.

Locations

Country	Name	City	State
China	West China Hospital, Sichuan University, Phase I Unit	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax: Maximum Observed Plasma Concentration for Bismuth		Day 14: 0 to 12 hours after the morning dose
Primary	AUCt: Area Under the Plasma Concentration-time Curve During a Dosing Interval t for Bismuth		Day 14: 0 to 12 hours after the morning dose
Primary	Aet: Total Amount of Bismuth Excreted in Urine During a Dosing Interval t for Bismuth		Day 14: 0 to 12 hours after the morning dose
Secondary	Percentage of Participants Who Experience at Least One Treatment-Emergent Adverse Event (TEAE)	An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an AE with an onset that occurs after receiving study drug.	From the first dose of study drug up to Day 17
Secondary	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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