Famotidine or Rabeprazole for Healthy Volunteers
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to study how two medications, famotidine (an acid reducer) and rabeprazole (a proton pump inhibitor), affect the processing of a drug called nirogacestat in the body. Researchers will administer nirogacestat alone and then with each of the other medications to observe any differences in drug processing. The trial seeks healthy male participants who have no major health conditions and do not take medications that might affect the results. Participants should not have any current infections or recent illnesses. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Do I have to stop taking my current medications for the trial?
Yes, you will need to stop taking any prescription or non-prescription drugs, including vitamins and dietary or herbal supplements, at least 3 weeks before the study starts. Additionally, you must not use long-acting gastric acid-reducing agents, like H2 blockers and PPIs, within 21 days of the study.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have reported that famotidine can cause side effects like headaches, nausea, and stomach issues. These effects are common and usually not serious. Famotidine, often used to treat stomach problems like heartburn, has been around for a while and is generally considered safe.
Studies involving over a thousand patients showed that rabeprazole is well-tolerated. Some participants experienced mild side effects, such as digestive issues, and in rare cases, allergic reactions. Rabeprazole is also a common medication for stomach issues and is usually safe when used as directed.
Both treatments have been widely used for other conditions, providing extensive safety information. While mild side effects are possible, serious problems are rare.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the treatments using famotidine and rabeprazole because they offer new ways to manage conditions like acid reflux or ulcers. Unlike standard treatments that primarily focus on reducing stomach acid with a single medication, this approach combines these drugs with nirogacestat, which might enhance effectiveness by targeting different pathways. Famotidine and rabeprazole are both known for their acid-reducing capabilities, but their combination with nirogacestat could potentially improve how quickly and effectively symptoms are managed, offering a more comprehensive treatment strategy.
What evidence suggests that this trial's treatments could be effective?
This trial will compare the effects of Famotidine and Rabeprazole in healthy volunteers. Research has shown that Famotidine reduces stomach acid and often heals stomach and duodenal ulcers, yielding positive results. Similarly, Rabeprazole effectively reduces acid and prevents acid-related symptoms. Studies have demonstrated its success in preventing symptom recurrence. Both treatments lower stomach acid, aiding in various digestive issues.678910
Who Is on the Research Team?
Mary Beth Brune, MD
Principal Investigator
Medpace, Inc.
Are You a Good Fit for This Trial?
This clinical trial is for healthy male participants. Specific eligibility criteria are not provided, but typically, trials require individuals to be within a certain age range and have no serious underlying health conditions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive nirogacestat alone or with famotidine or rabeprazole in a 3-period crossover design
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Famotidine
- Rabeprazole
Trial Overview
The study is testing how the drugs famotidine (an H2 blocker) or rabeprazole (a PPI - proton pump inhibitor) affect the pharmacokinetics (how the body processes) of nirogacestat in healthy men.
How Is the Trial Designed?
3
Treatment groups
Active Control
Nirogacestat will be administered, after at least a 10-hour fast, in the morning on Day 1, Day 6, and Day 17
Rabeprazole will be administered as an oral tablet in the evenings on Day 10 through Day 16.
Famotidine will be administered as an oral tablet 2 hours after the administration of nirogacestat on Day 6.
Find a Clinic Near You
Who Is Running the Clinical Trial?
SpringWorks Therapeutics, Inc.
Lead Sponsor
Citations
Famotidine - StatPearls - NCBI Bookshelf - NIH
Famotidine reduces gastric acid secretion in individuals, and its pharmacological properties are utilized in treating gastrointestinal conditions related to ...
2.
clinicaltrials.gov
clinicaltrials.gov/study/NCT05866627?intr=FAMOTIDINE&aggFilters=studyType:int&viewType=Table&rank=9A Study to Assess the Effect of Famotidine on the Drug ...
Study Overview. The purpose of this study is to confirm there is no significant effect of gastric pH changes of famotidine on the drug levels of afimetoran in ...
Effect of Famotidine on Outcomes in Pulmonary Arterial ...
No significant difference in the primary outcome of 6MWD at 24 weeks was found, with an increase of 4.7 m seen in the placebo arm vs a decrease of 17.0 m in the ...
Famotidine use and quantitative symptom tracking for ...
Conclusions The results of this case series suggest that high-dose oral famotidine is well tolerated and associated with improved patient-reported outcomes in ...
Famotidine. An updated review of its pharmacodynamic ...
As shown in placebo-controlled trials, famotidine is effective in healing both duodenal and gastric ulcers. Famotidine 20mg twice daily or 40mg at bedtime ...
Safety Data Sheet
Chemical safety assessment: A Chemical Safety Assessment has not been carried out. 16 Other information. All chemicals may pose unknown hazards ...
Material Safety Data Sheet
Known Clinical Effects: Adverse effects most commonly reported in clinical use include headache, nausea and gastrointestinal disturbances.
SAFETY DATA SHEET
Handle in accordance with good industrial hygiene and safety practice. Stable under normal conditions. Hazardous Polymerization Hazardous polymerization does ...
SAFETY DATA SHEET
Precautionary Statements - EU (§28, 1272/2008). P261 - Avoid breathing dust, fume, gas, mist, vapors and spray. P264 - Wash face, hands and any exposed skin ...
Famotidine (oral route) - Side effects & dosage
Famotidine is used to treat stomach ulcers (gastric and duodenal), erosive esophagitis (heartburn or acid indigestion), and gastroesophageal reflux disease ( ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.