A Study to Investigate the Effects of Acid Reducing Agents on Pharmacokinetics of PC14586 in Heal… (NCT06054464) | Clinical Trial Compass
CompletedPhase 1
A Study to Investigate the Effects of Acid Reducing Agents on Pharmacokinetics of PC14586 in Healthy Participants
United States28 participantsStarted 2023-09-19
Plain-language summary
This study will assess the effect of a Proton Pump Inhibitor (PPI) (rabeprazole) on the pharmacokinetics (PK) of PC14586 and the effect of an H2-receptor antagonist (famotidine) on the PK of PC14586
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Healthy, non-smoking males and females, 18-55 years of age, with BMI between 18.5 - 30 kg/m2 inclusive.
. Agree to use a highly effective method of contraception from 14 days before check-in through 90 days after last dose of study drug.
. Participants who are capable of giving signed informed consent.
Exclusion criteria
. Participants with significant history or clinical manifestation of any medical condition, disease or disorder, as determined by the Investigator.
. Positive hepatitis panel and/or positive human immunodeficiency virus test.
. Use or intend to use any prescription and/or nonprescription medications/products within 14 days prior to check-in.
. Participation in a clinical study involving last administration of an investigational drug within the past 30 days prior to screening.
. Participant has blood pressure \> 140 mm systolic or \> 90 mm diastolic at Screening or Day - 1.
. Participants with a germline TP53 Y220C mutation at Screening.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Part 1: Characterize the Maximum Plasma Concentration (Cmax) of PC14586 when co-administered with rabeprazole.
Timeframe: 20 days
2
Part 1: Characterize the total drug exposure to the last measurable concentration (AUC0-last) of PC14586 when co-administered with rabeprazole.
Timeframe: 20 days
3
Part 1: Characterize the total drug exposure (AUC0-inf) of PC14586 when co-administered with rabeprazole.
Timeframe: 20 days
4
Part 1: Characterize the time to peak drug concentration (Tmax) of PC14586 when co-administered with rabeprazole.
Timeframe: 20 days
5
Part 2: Characterize the Maximum Plasma Concentration (Cmax) of PC14586 when co-administered with famotidine.
Timeframe: 20 days
6
Part 2: Characterize the total drug exposure to the last measurable concentration (AUC0-last) of PC14586 when co-administered with famotidine.
. Participant has smoked or used other nicotine-containing products (snuff, chewing tobacco, cigars, pipes, vaporizer, or nicotine-replacement products such as nicotine chewing gum and nicotine plasters) during the 3 months before the Screening Visit.
. Participant has history of alcohol and/or illicit drug abuse within 5 years of Screening.
Part 2: Characterize the total drug exposure (AUC0-inf) of PC14586 when co-administered with famotidine.
Timeframe: 20 days
8
Part 2: Characterize the time to peak drug concentration (Tmax) of PC14586 when co-administered with famotidine.