drugset / Trial / NCT03192111

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

NCT03192111

Phase 1 Completed 40 enrolled Syndax Pharmaceuticals
Non-randomizedParallel-groupOpen-labelOther

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.

Timeline

Start
2017-07-27
Primary completion
2017-11-23
Completion
2017-11-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Entinostat Small molecule