Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06302140
Status:
RECRUITING
Last Update Posted:
2024-03-29
First Post:
2024-02-23
Brief Title:
A Mass Balance Study of 14C-Nanatinostat and Relative Bioavailability Study of Nanatinostat in Patients With Advanced Cancers
Sponsor:
Viracta Therapeutics Inc
Organization:
Viracta Therapeutics Inc
Study Overview
Official Title:
A Phase 1 Study to Investigate the Mass Balance of 14C-Nanatinostat and to Evaluate the Relative Bioavailability of Nanatinostat in Patients With Selected Advanced Cancers
Status:
RECRUITING
Status Verified Date:
2024-03
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 determine how nanatinostat is absorbed modified and removed from the body Part A the amount of nanatinostat that becomes available to the body Part B and will evaluate the safety and tolerability of nanatinostat Part C in patients with advanced cancers
Detailed Description:
This is a Phase 1 open-label 3-part study evaluating the mass balance pharmacokinetics and metabolism of nanatinostat following a single oral dose of 14C-nanatinostat for Part A evaluating relative bioavailability of nanatinostat mesylate and nanatinostat free base tablets after coadministration with valganciclovir in patients with advanced stage cancers for Part B and evaluating the safety and antitumor activity of nanatinostat for Part C
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?:
True
Is an FDA AA801 Violation?:
None