NCT03192111

A Study to Evaluate the Pharmacokinetics of Entinostat in Adult Subjects With Normal and Impaired Renal Function

A Phase 1, Open-Label, Parallel-Cohort, Single-Dose Study to Evaluate the Pharmacokinetics of Entinostat in Adult Subjects With Normal and Impaired Renal Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Syndax Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This purpose of this study is to evaluate the effects of a single dose of entinostat on subjects with varying levels of renal impairment. The primary objective of this study is to evaluate the pharmacokinetics of a single dose of entinostat in adult subjects with mild, moderate and severe renal impairment compared to healthy mean-matched subjects. The secondary objective of this study is to evaluate the safety and tolerability of entinostat in adult subjects with mild, moderate, and severe renal impairment and in healthy mean-matched adult subjects.

Conditions

• Renal Impairment
• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	Entinostat	HDAC (histone deacetylase) inhibitor

Timeline

• Start date: 2017-07-27
• Primary completion: 2017-11-23
• Completion: 2017-11-23
• First posted: 2017-06-19
• Last updated: 2018-04-13

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study