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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 belowSelect...
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
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 moreSecondary 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 moreAwards & 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
~40
Famotidine
2005
Completed Phase 4
~1700
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].
[Effects of Huoxue Qianyang Formula on expressions of proto-oncogenes c-fos and c-myc in spontaneous hypertensive rats with ventricular hypertrophy].
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
PMV Pharmaceuticals, IncLead Sponsor
5 Previous Clinical Trials
313 Total Patients Enrolled
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