Trials / Completed
CompletedNCT02929342
Study to Assess the Absorption, Distribution, Metabolism and Excretion (ADME) of [14C]-Pitolisant in Healthy Male Volunteers
An Open Label, Single-Period Repeated Dose Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-Pitolisant, at Steady-State Conditions, in Healthy CYP2D6 Genotyped Male Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 8 (actual)
- Sponsor
- Bioprojet · Academic / Other
- Sex
- Male
- Age
- 30 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to better define the absorption and elimination pathways, and circulating metabolites of Pitolisant at steady state using Pitolisant radiolabelled, in healthy CYP2D6 genotyped male subject.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pitolisant | |
| RADIATION | [14C]-Pitolisant |
Timeline
- Start date
- 2016-07-01
- Primary completion
- 2016-08-01
- Completion
- 2016-08-01
- First posted
- 2016-10-11
- Last updated
- 2016-10-11
Source: ClinicalTrials.gov record NCT02929342. Inclusion in this directory is not an endorsement.