Trials / Completed
CompletedNCT03495934
A Study In Healthy Male Volunteers Designed To Investigate How A Radiolabelled Medicine Is Broken Down And Removed From The Body
An Open Label, Single-dose, Single-period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-Pracinostat in Healthy Male Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- Helsinn Healthcare SA · Industry
- Sex
- Male
- Age
- 40 Years – 65 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | pracinostat | \[14C\]-pracinostat |
Timeline
- Start date
- 2018-02-08
- Primary completion
- 2018-02-28
- Completion
- 2018-02-28
- First posted
- 2018-04-12
- Last updated
- 2019-08-08
Locations
1 site across 1 country: United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03495934. Inclusion in this directory is not an endorsement.