Status:
COMPLETED
A Study to Investigate the Effects of Acid Reducing Agents on Pharmacokinetics of PC14586 in Healthy Participants
Lead Sponsor:
PMV Pharmaceuticals, Inc
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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
Detailed Description
PC14586 is a first-in-class, oral, small molecule p53 reactivator that is selective for the TP53 Y220C mutation. This study will investigate the effects of acid reducing agents on the pharmacokinetics...
Eligibility Criteria
Inclusion
- 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
- 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.
- 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.
- Participant is unwilling to avoid use of alcohol or alcohol-containing foods, medications, or beverages, 48 hours prior to admission until discharge from the study center.
- 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.
- Female participant that is breastfeeding (or bottle feeding with their breast milk) or female participant with a positive serum pregnancy test at the Screening Visit or positive serum or urine pregnancy test at Day -1 (admission).
Key Trial Info
Start Date :
September 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 6 2024
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT06054464
Start Date
September 19 2023
End Date
February 6 2024
Last Update
November 13 2024
Active Locations (1)
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1
Parexel International
Baltimore, Maryland, United States, 21225