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Rabeprazole for Clinical Trials

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

PC

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

I am a healthy adult man or a woman who cannot become pregnant, aged 18 to 65.
My BMI is between 16 and 32, and I weigh more than 50 kg (110 lb).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive single-dose administrations of PF-07799933 and PF-07799544 under different conditions including fasting, fed, and with rabeprazole

Up to 35 days
Multiple visits for each cohort period

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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

Group I: PF-07799933 Form 2 Tablet Arm following Rabeprazole PretreatmentExperimental Treatment1 Intervention
Group II: PF-07799933 Form 2 Tablet ArmExperimental Treatment1 Intervention
Group III: PF-07799933 Form 2 Film-Coated Tablet Arm with PF-07799544 under Fed ConditionsExperimental Treatment1 Intervention
Group IV: PF-07799933 Form 2 Film-Coated Tablet Arm with PF-07799544 FastedExperimental Treatment1 Intervention
Group V: PF-07799933 Form 1 Tablet Arm with PF-07799544 FastedExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials
4,712
Recruited
50,980,000+
Known For
Vaccine Innovations
Top Products
Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni profile image

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/20132154/

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