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

NCT ID: NCT06054464

Last Updated: 2024-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-19
• Study Completion Date: 2024-02-06

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 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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Part 1: PC14586 and rabeprazole

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.

Group Type: EXPERIMENTAL

PC14586

Intervention Type: DRUG

Part 1 and Part 2: Single, oral dose of PC14586 on day 1 and single, oral dose of PC14586 on day 14.

Rabeprazole

Intervention Type: DRUG

Part 1: Daily oral dose of rabeprazole on days 11-14.

Part 2: PC14586 and famotidine

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 Type: EXPERIMENTAL

PC14586

Intervention Type: DRUG

Part 1 and Part 2: Single, oral dose of PC14586 on day 1 and single, oral dose of PC14586 on day 14.

Famotidine

Intervention Type: DRUG

Part 2: Twice daily oral dose of famotidine on days 11-13. Single, oral dose of famotidine on day 14.

Interventions

PC14586

Part 1 and Part 2: Single, oral dose of PC14586 on day 1 and single, oral dose of PC14586 on day 14.

Intervention Type: DRUG

Rabeprazole

Part 1: Daily oral dose of rabeprazole on days 11-14.

Intervention Type: DRUG

Famotidine

Part 2: Twice daily oral dose of famotidine on days 11-13. Single, oral dose of famotidine on day 14.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Healthy, non-smoking males and females, 18-55 years of age, with BMI between 18.5 - 30 kg/m2 inclusive.

2. Agree to use a highly effective method of contraception from 14 days before check-in through 90 days after last dose of study drug.

3. Participants who are capable of giving signed informed consent.

Exclusion Criteria

1. Participants with significant history or clinical manifestation of any medical condition, disease or disorder, as determined by the Investigator.

2. Positive hepatitis panel and/or positive human immunodeficiency virus test.

3. Use or intend to use any prescription and/or nonprescription medications/products within 14 days prior to check-in.

4. Participation in a clinical study involving last administration of an investigational drug within the past 30 days prior to screening.

5. Participant has blood pressure > 140 mm systolic or > 90 mm diastolic at Screening or Day - 1.

6. Participants with a germline TP53 Y220C mutation at Screening.

7. 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.

8. Participant has history of alcohol and/or illicit drug abuse within 5 years of Screening.

9. 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.

10. 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.

11. 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

PMV Pharmaceuticals, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Parexel International

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

PMV-586-104

Identifier Type: -

Identifier Source: org_study_id