NCT05523687

AME Study of [14C]-PC14586 in Healthy Male Participants

A Phase 1, Open-label Study of the Absorption, Metabolism, Excretion of [14C]-PC14586 Following a Single Oral Dose in Healthy Male Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: PMV Pharmaceuticals, Inc · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study will assess the PK and rates of elimination and mass balance of total radioactivity from \[14C\]-PC14586

Detailed description

PC14586 is a first-in-class, oral, small molecule p53 reactivator that is selective for the TP53 Y220C mutation. The study will assess the PK, absorption, metabolism, and excretion of \[14C\]-PC14586 following a single dose in healthy male participants. The aim is to recruit approximately 8 participants with a minimum number of 6 evaluable participants. Each participant will be admitted to the study site pre-dose on Day -1 and will remain at the study site until at least Day 14. Participants will receive a single administration of \[14C\]-PC14586 as oral capsules on Day 1. During this study, whole blood, plasma, urine, feces, and vomit samples (if presented) will be collected at various timepoints to characterize the absorption, metabolism, excretion, and PK of \[14C\]-PC14586. The duration of the residential period will be evaluated following the administration of \[14C\]-PC14586 and may be extended to ensure recovery of at least 90% of the total radioactivity, or until less than 1% of dose is recovered in urine and/or feces.

Conditions

• Healthy Male Volunteers

Interventions

Type	Name	Description
DRUG	[14C]-PC14586	Single, oral dose of \[14C\]-PC14586

Timeline

• Start date: 2022-09-06
• Primary completion: 2022-11-30
• Completion: 2022-11-30
• First posted: 2022-08-31
• Last updated: 2022-12-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study