NCT06302140

A Mass Balance Study of [14C]-Nanatinostat and Relative Bioavailability Study of Nanatinostat in Patients With Advanced Cancers

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: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Viracta Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. The study was terminated prematurely and did not reach its target enrollment.

Conditions

• Advanced Cancer

Interventions

Type	Name	Description
DRUG	[14C]-Nanatinostat	A single oral dose administered on Day 1 in a fasted state.
DRUG	Nanatinostat (free base) tablets in combination with Valganciclovir	Treatment A: a single, oral dose of nanatinostat (free base) tablets (20 mg) in combination with valganciclovir (900 mg) under fed conditions.
DRUG	Nanatinostat mesylate tablets in combination with Valganciclovir	Treatment B: a single, oral dose of nanatinostat mesylate tablets (20 mg) in combination with valganciclovir (900 mg) under fed conditions.
DRUG	Single-agent Nanatinostat (free base) tablets	40 mg once daily under fed conditions until disease progression or unacceptable toxicity, whichever occurs first.

Timeline

• Start date: 2024-02-28
• Primary completion: 2025-01-15
• Completion: 2025-01-15
• First posted: 2024-03-08
• Last updated: 2025-01-20

Locations

1 site across 1 country: Spain

Regulatory

• FDA-regulated drug study