Clinical trial NCT04753437: A Study of Vonoprazan in Adults With Helicobacter Pylori
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Helicobacter Pylori
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2021-02-15
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cmax: Maximum Observed Plasma Concentration for Bismuth
timeFrame: Day 14: 0 to 12 hours after the morning dose
measure: AUCτ: Area Under the Plasma Concentration-time Curve During a Dosing Interval τ for Bismuth
timeFrame: Day 14: 0 to 12 hours after the morning dose
measure: Aeτ: Total Amount of Bismuth Excreted in Urine During a Dosing Interval τ for Bismuth
timeFrame: Day 14: 0 to 12 hours after the morning dose
Secondary outcomes:
measure: Percentage of Participants Who Experience at Least One Treatment-Emergent Adverse Event (TEAE)
timeFrame: From the first dose of study drug up to Day 17
measure: Percentage of Participants Who Discontinued Study Drug Due to a Treatment-Emergent Adverse Event (TEAE)
timeFrame: From the first dose of study drug up to Day 17
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital, Sichuan University, Phase I Unit
state: Sichuan
Study officials:
affiliation: Takeda
name: Medical Director
role: STUDY_DIRECTOR
References: