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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20 days
Awards & highlights

Study Summary

This trial will look at how two drugs affect the body's absorption of a third drug, PC14586.

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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

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
PC14586
2021
Completed Phase 1
~40
Rabeprazole
2017
Completed Phase 4
~3920
Famotidine
2005
Completed Phase 4
~1700

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

PMV Pharmaceuticals, IncLead Sponsor
4 Previous Clinical Trials
288 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are geriatric individuals eligible for enrolment in this clinical trial?

"This trial has set the lower age limit at 18 and the upper threshold at 55 to ensure that all patients meet eligibility criteria."

Answered by AI

Is participation in this research project open to me?

"To qualify for participation, potential patients must be between 18 and 55 years old with no underlying conditions. This trial will accept a maximum of 50 subjects."

Answered by AI

Are the components of Part 1: PC14586 and rabeprazole in compliance with FDA regulations?

"Due to the limited research available on this intervention, our team has assigned it a safety rating of 1. This is due to PC14586 and rabeprazole being in Phase 1 trials with minimal supporting evidence for both safety and efficacy."

Answered by AI

Are there any available openings for participants of this clinical research study?

"As per records on clinicaltrials.gov, this trial is no longer enrolling patients. The initial posting occurred September 1st 2023 and the last update was made 19th of that same month. Fortunately, 836 other medical trials are currently recruiting participants to participate in their research initiatives."

Answered by AI

What effects are researchers hoping to observe through this clinical trial?

"This 20-day study seeks to quantify the total drug exposure of PC14586 when co-administered with rabeprazole in terms of AUC0-last, AUC0-96 and % extrapolation. Additionally, it will determine the half life (t1/2) of PC14586 under this combination therapy."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Investigate the Effects of Acid Reducing Agents on Pharmacokinetics of PC14586 in Healthy Participants
2023. "A Study to Investigate the Effects of Acid Reducing Agents on Pharmacokinetics of PC14586 in Healthy Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06054464.
~18 spots leftby Apr 2025
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