What is the mechanism of action of this treatment?

Rabeprazole, a Proton Pump Inhibitor (PPI), works by blocking the enzyme in the stomach wall responsible for acid production, thereby significantly reducing stomach acid levels. Famotidine, an H2-receptor antagonist, reduces acid production by blocking histamine receptors in the stomach. These treatments are important for healthy subjects as they help manage and prevent conditions like gastroesophageal reflux disease (GERD) by minimizing acid-related damage and alleviating symptoms, thus improving overall digestive health and comfort.

What side effects are associated with this type of intervention?

Rabeprazole, a Proton Pump Inhibitor, is generally well-tolerated but can cause side effects such as headache, abdominal pain, nausea, and diarrhea. Famotidine, an H2-receptor antagonist, may also cause side effects including headache, dizziness, constipation, and diarrhea. Both medications are used to reduce stomach acid and treat conditions like gastroesophageal reflux disease (GERD).

What prior FDA approvals exist?

Proton Pump Inhibitors (PPIs) such as omeprazole, lansoprazole, and esomeprazole have been FDA-approved for treating conditions like gastroesophageal reflux disease (GERD), peptic ulcer disease, and Zollinger-Ellison syndrome. Similarly, H2-receptor antagonists like cimetidine, ranitidine, and nizatidine have been approved for reducing stomach acid production and treating ulcers and GERD. These drug classes are well-established for managing acid-related disorders.

What other types of research exist?

A promising novel alternative to Rabeprazole and Famotidine is vonoprazan, a potassium-competitive acid blocker (P-CAB). Vonoprazan has shown efficacy in inhibiting gastric H(+), K(+)-ATPase, providing a new mechanism for acid suppression. Additionally, combination therapy with mosapride citrate and omeprazole has shown improved outcomes in patients with PPI-resistant non-erosive reflux disease (NERD) and delayed gastric emptying.

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Acid Reducing Agents' Effects on PC14586 Absorption in Healthy Participants

Phase 1

Waitlist Available

Research Sponsored by PMV Pharmaceuticals, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Healthy, non-smoking males and females, 18-55 years of age, with BMI between 18.5 - 30 kg/m2 inclusive

Be between 18 and 65 years old

Must not have

Participants with a germline TP53 Y220C mutation at Screening

Participant has a history of hypersensitivity to the study drug (PC14586), rabeprazole (Part 1), or famotidine (Part 2) or any of the excipients or to medicinal products with similar chemical structures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 20 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing how two stomach acid-reducing drugs, rabeprazole and famotidine, affect the body's handling of a new drug called PC14586. PC14586 is designed to target a specific mutation in a protein linked to cancer. Healthy volunteers will take these medications to see if they change how much PC14586 gets into their blood and how fast it is processed.

Who is the study for?

This trial is for healthy, non-smoking men and women aged 18-55 with a BMI of 18.5 - 30 kg/m2 who can consent to the study. They must not have used nicotine or certain medications recently, avoid alcohol before admission, and agree to use effective contraception.

What is being tested?

The study tests how acid-reducing drugs like Rabeprazole (a PPI) and Famotidine (an H2 antagonist) affect the body's handling of PC14586, a drug under investigation.

What are the potential side effects?

While specific side effects are not listed for this trial, common ones for PPIs include headaches, diarrhea, nausea; H2 antagonists may cause headache or gastrointestinal issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a healthy, non-smoking adult aged 18-55 with a BMI of 18.5-30.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a TP53 Y220C genetic mutation.

Select...

I am allergic to the study drug or similar medications.

Select...

I am currently breastfeeding or have tested positive for pregnancy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 20 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~20 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 20 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part 1: Characterize the Maximum Plasma Concentration (Cmax) of PC14586 when co-administered with rabeprazole.

Part 1: Characterize the time to peak drug concentration (Tmax) of PC14586 when co-administered with rabeprazole.

Part 1: Characterize the total drug exposure (AUC0-inf) of PC14586 when co-administered with rabeprazole.

+5 more

Secondary study objectives

Part 1: Characterize the apparent terminal elimination rate (lambda Z) for PC14586 when co-administered orally with rabeprazole.

Part 1: Characterize the clearance (CL/F) for PC14586 when co-administered orally with rabeprazole.

Part 1: Characterize the half-life (t1/2) for PC14586 when co-administered with rabeprazole.

+19 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part 2: PC14586 and famotidineExperimental Treatment2 Interventions

Healthy participants will receive a single, oral dose of PC14586 on day 1. On days 11-13, participants will receive a twice daily, oral dose of famotidine. On day 14, participants will receive PC14586 two hours before a dose of famotidine. Participants will be given a low-fat meal 30 minutes prior to PC14586 dosing.

Group II: Part 1: PC14586 and rabeprazoleExperimental Treatment2 Interventions

Healthy participants will receive a single, oral dose of PC14586 on day 1. On days 11-13, participants will receive an oral daily dose of rabeprazole. On day 14, participants will receive a co-administration dose of rabeprazole and PC14586. Rabeprazole will be given 1 hour prior to PC14586. Participants will be given a low-fat meal 30 minutes prior to PC14586 dosing.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rabeprazole

2017

Completed Phase 4

~4220

PC14586

2021

Completed Phase 1

~80

Famotidine

2005

Completed Phase 4

~1220

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Rabeprazole, a Proton Pump Inhibitor (PPI), works by blocking the enzyme in the stomach wall responsible for acid production, thereby significantly reducing stomach acid levels. Famotidine, an H2-receptor antagonist, reduces acid production by blocking histamine receptors in the stomach. These treatments are important for healthy subjects as they help manage and prevent conditions like gastroesophageal reflux disease (GERD) by minimizing acid-related damage and alleviating symptoms, thus improving overall digestive health and comfort.

[Effects of Huoxue Qianyang Formula on expressions of proto-oncogenes c-fos and c-myc in spontaneous hypertensive rats with ventricular hypertrophy].