A Study to Investigate the Effects of Acid Reducing Agents on Pharmacokinetics of PC14586 in Healthy Participants

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 of PC14586.

This is a 2-part, open-label, two-period, fixed-sequence study in healthy participants with each participant used as his/her own control to assess the effect of rabeprazole (Part 1) or famotidine (Part 2) on the PK of PC14586. The results from Part 1 will be analyzed before deciding to, if applicable, progress to Part 2. Part 2 of the study will only be initiated if the findings from Part 1 show an interaction or are inconclusive.

Approximately 25 participants will be enrolled in Part 1 and approximately 25 participants will be enrolled in Part 2. The Study timelines reflect both Part 1 and Part 2.

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.
• 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).