NCT06362642

A Study to Investigate the Effects of Itraconazole on the Pharmacokinetics of PC14586 in Healthy Participants

A Phase 1, Open-label, Fixed-sequence Study to Investigate the Effect of Coadministration of Itraconazole on the Pharmacokinetics of PC14586 in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: PMV Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the effect of PC14586 pharmacokinetics when co administered with itraconazole in healthy participants.

Detailed description

PC14586 is a first-in-class, oral, small molecule p53 reactivator that is selective for the TP53 Y220C mutation. This is a Phase 1, open-label, fixed-sequence study to investigate the effect of coadministration of itraconazole on the pharmacokinetics (PK) of PC14586 (rezatapopt) in healthy male and female participants. Potential participants will be screened to assess their eligibility to enter the study within 56 days prior to the first dose administration. Participants will be admitted into the study site on Day -1 and be confined to the study site until discharge on Day 33. Participants will return to the study site for PK sample collection on Day 37 and a follow-up visit and PK sample collection on Day 42. Approximately 16 participants will be enrolled in this study.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	PC14586	First-in-class, oral, small molecule p53 reactivator that is selective for the TP53 Y220C mutation.
DRUG	Itraconazole	Antifungal treatment that is a potent inhibitor of CYP3A4.

Timeline

• Start date: 2024-03-28
• Primary completion: 2024-10-22
• Completion: 2024-10-22
• First posted: 2024-04-12
• Last updated: 2024-11-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study