drugset / Trial / NCT03495934

A Study In Healthy Male Volunteers Designed To Investigate How A Radiolabelled Medicine Is Broken Down And Removed From The Body

NCT03495934

Phase 1 Completed 6 enrolled Helsinn Healthcare SA Quotient Sciences · collab
NaSingle-groupOpen-labelOther

Summary

The current study is designed to generate data for the investigation of absorption, distribution, metabolism and elimination (ADME) processes of pracinostat in humans, as well as generating samples for metabolite profiling and structural identification. The mass balance recovery of pracinostat following administration of \[14C\]-pracinostat will be assessed, as well as metabolite profiling and identification of pracinostat in healthy male subjects. In addition, this study will provide further PK and safety data in healthy subjects.

Timeline

Start
2018-02-08
Primary completion
2018-02-28
Completion
2018-02-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Pracinostat Other / unclassified Oral

Indications

No indication recorded.