Ignite Creation Date:
2024-05-06 @ 6:03 PM
Last Modification Date:
2024-10-26 @ 2:40 PM
Study NCT ID:
NCT05523687
Status:
COMPLETED
Last Update Posted:
2022-12-20
First Post:
2022-08-22
Brief Title:
AME Study of 14C-PC14586 in Healthy Male Participants
Sponsor:
PMV Pharmaceuticals Inc
Organization:
PMV Pharmaceuticals Inc
Study Overview
Official Title:
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
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 andor feces
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 andor feces
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None