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

NCT06302140 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2025-01-20

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Viracta Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Darrel P Cohen, MD, PhD · Viracta Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-28
Primary Completion
2025-01-15
Completion
2025-01-15
FDA Drug
Yes

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06302140 on ClinicalTrials.gov