Rabeprazole for Clinical Trials
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new form of a medication to compare its absorption in the body with the current version. It also examines the effects of a high-fat meal or a stomach acid reducer (such as rabeprazole) on the medication's absorption. This study is ideal for healthy individuals without significant medical conditions or drug allergies. The results will help determine the best way to administer the medication in future studies. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new medication.
Do I need to stop taking my current medications to join the trial?
Yes, you will need to stop taking most prescription and nonprescription drugs, as well as dietary and herbal supplements, at least 7 days or 5 half-lives before the first dose of the study drug. Proton pump inhibitors and certain other medications have specific restrictions, so it's important to discuss your current medications with the study team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that rabeprazole is generally safe for most people. Side effects are usually mild and can include headaches, diarrhea, and stomach pain. These occur in a small number of people, with headaches affecting up to 10% of users. Other possible side effects include nausea, constipation, and gas. Serious side effects are rare, but if any symptoms become bothersome, consulting a doctor is important. Overall, rabeprazole is considered safe, especially since the FDA has approved it for other conditions related to reducing stomach acid.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments because they explore Rabeprazole's potential to enhance the effectiveness of PF-07799933, particularly when used in combination with PF-07799544. Rabeprazole, a proton pump inhibitor, is commonly used to reduce stomach acid, potentially improving the absorption and efficacy of PF-07799933. Unlike standard treatments that may not consider such interactions, this trial investigates how timing and conditions, like fasting or fed states, impact the drug's performance. By fine-tuning these variables, the study aims to optimize treatment outcomes, paving the way for potentially more effective therapeutic strategies.
What evidence suggests that this trial's treatments could be effective?
Rabeprazole treats problems caused by stomach acid, such as heartburn and stomach ulcers. Studies have shown that about 95% of people taking rabeprazole experience no symptoms after long-term use. This medication reduces stomach acid production, preventing ulcers and easing acid reflux symptoms. Research involving over 1,000 patients found rabeprazole safe and effective for managing gastroesophageal reflux disease (GERD). Doctors regard rabeprazole highly for its ability to manage and prevent issues related to stomach acid. In this trial, one treatment arm involves participants receiving PF-07799933 film-coated tablets following rabeprazole pretreatment.678910
Who Is on the Research Team?
Pfizer CT.gov Call Center
Principal Investigator
Pfizer
Are You a Good Fit for This Trial?
This trial is for healthy men and women (not able to have children), ages 18-65, with a BMI between 16 and 32, and weighing over 50 kg (110 lbs). Participants must be in good health based on medical exams, lab tests, vital signs, and heart checks.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive single-dose administrations of PF-07799933 and PF-07799544 under different conditions including fasting, fed, and with rabeprazole
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Rabeprazole
Trial Overview
The study compares how the body absorbs different forms of the drug PF-07799933 alone or with PF-07799544 under various conditions: after fasting, after eating a high-fat meal, or after taking an acid-reducing medicine called rabeprazole. All drugs are given as single doses.
How Is the Trial Designed?
5
Treatment groups
Experimental Treatment
Cohort 2 Period 1: Participants receive PF-07799933 film-coated tablets following rabeprazole treatment
Cohort 2 Period 1: Participants receive PF-07799933 film-coated tablets
Cohort 1 Period 3: Participants receive PF-07799933 film-coated tablets in Combination With PF-07799544 following a High-Fat Meal
Cohort 1 Period 2: Participants receive PF-07799933 film-coated tablets in Combination With PF-07799544
Cohort 1 Period 1: Participants receive PF-07799933 tablets in Combination With PF-07799544
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pfizer
Lead Sponsor
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University
Citations
maintenance intermittent therapy with rabeprazole 20 mg ...
Patients with complete heartburn control after 4 weeks of open-label rabeprazole 20 mg daily treatment were randomized to 6-month, double-blind, maintenance ...
A Randomized, Double Blinded, Clinical Trial to Assess the ...
At the end of 42 weeks of maintenance therapy, 96.4% of omeprazole and 95.1% of rabeprazole treated patients remained symptom free ( > 0.05). Two drugs were ...
Safety and Efficacy of Rabeprazole in Infants With ...
The purpose of this study is to assess the effectiveness and safety of rabeprazole sodium, an inhibitor of gastric acid secretion of the protein pump ...
Real-world-evidence, prospective-observational study to ...
Overall, the novel rabeprazole DDR formulation has demonstrated safety and efficacy in managing GERD, supported by data from 1022 patients. One ...
Long-term efficacy and safety of rabeprazole in patients taking ...
The use of long-term rabeprazole 10- and 5-mg once daily prevents the recurrence of peptic ulcers in subjects on low-dose aspirin therapy, and both were well- ...
Rabeprazole (oral route) - Side effects & dosage
Bloating or swelling of the face, arms, hands, lower legs, or feet · chills · cough · dark urine · dry mouth · fever · general feeling of tiredness and weakness ...
Rabeprazole (AcipHex) - Uses, Side Effects, and More
What are the most common side effects of rabeprazole? · Pain · Sore throat · Gas · Infection · Constipation · Headache (children ages 12 to 17) ...
Rabeprazole Side Effects: Common, Severe, Long Term
General adverse events. The most commonly reported side effects are headache, diarrhea, and abdominal pain. Gastrointestinal. Very common ...
ACIPHEX®(rabeprazole sodium) Label - accessdata.fda.gov
ACIPHEX may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor. ACIPHEX can cause serious side effects, ...
A Comprehensive Safety Profile of Rabeprazole
Conclusion: This study identifies multi-system safety signals for rabeprazole, notably delayed renal toxicity and early gastrointestinal or ...
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