Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06362642
Status:
RECRUITING
Last Update Posted:
2024-04-12
First Post:
2024-03-25
Brief Title:
A Study to Investigate the Effects of Itraconazole on the Pharmacokinetics of PC14586 in Healthy Participants
Sponsor:
PMV Pharmaceuticals Inc
Organization:
PMV Pharmaceuticals Inc
Study Overview
Official Title:
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:
RECRUITING
Status Verified Date:
2024-04
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:
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
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
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