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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-000748-32 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pitolisant | Experimental | Pitolisant, oral single dose administration, from Day1 to Day7. |
|
| [14C]-Pitolisant | Experimental | [14C]-Pitolisant, oral single dose administration at Day8. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pitolisant | Drug |
| ||
| [14C]-Pitolisant |
| Measure | Description | Time Frame |
|---|---|---|
| Mass balance recovery of total radioactivity (Ae) in urine, faeces and expired air. | from Day 8 (pre-dose) to 120 h post 14C-radioactivity dose | |
| Peak Plasma Concentration (Cmax), pitolisant and major metabolites. | From Day 1 (pre-dose) until 168hours post last dose | |
| Area under the plasma concentration versus time curve [AUC(0-tau), AUC(0-inf), %AUCextrap], pitolisant and major metabolites. | From Day 1 (pre-dose) until 168hours post last dose | |
| Volume of distribution (Vz/F), pitolisant and major metabolites. | From Day 1 (pre-dose) until 168hours post last dose | |
| Apparent clearance (Clss/F), pitolisant and major metabolites. | From Day 1 (pre-dose) until 168hours post last dose | |
| The slope of the apparent elimination phase (lambda-z), pitolisant and major metabolites. | From Day 1 (pre-dose) until 168hours post last dose | |
| The apparent elimination half-life (T½), pitolisant and major metabolites. | From Day 1 (pre-dose) until 168hours post last dose | |
| Time to reach Cmax (Tmax), pitolisant and major metabolites. | From Day 1 (pre-dose) until 168hours post last dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Litza McKenzie, MD | Quotient Clinical | Principal Investigator |
| Thierry Duvauchelle, MD | Bioprojet Pharma | Study Director |
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| ID | Term |
|---|---|
| C516975 | pitolisant |
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