Ignite Creation Date:
2024-05-06 @ 7:33 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06054464
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-12
First Post:
2023-09-08
Brief Title:
A Study to Investigate the Effects of Acid Reducing Agents on Pharmacokinetics of PC14586 in Healthy Participants
Sponsor:
PMV Pharmaceuticals Inc
Organization:
PMV Pharmaceuticals Inc
Study Overview
Official Title:
A Phase 1 Open-Label Non-Randomized Two-Part Fixed-Sequence Study to Evaluate the Effects of Acid Reducing Agents on the Pharmacokinetics of PC14586 in Healthy Volunteers
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-09
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 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 hisher 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
This is a 2-part open-label two-period fixed-sequence study in healthy participants with each participant used as hisher 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
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