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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-000735-32 | EudraCT Number |
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This study will evaluate the mass balance recovery and metabolite profile, and will identify metabolite structures following a single oral dose of 14C-XEN1101 in healthy adult male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug: (14C)-XEN1101 | Experimental | Subjects will receive oral 14C-XEN1101 under fed conditions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 14C-XEN1101 | Drug | Subjects will receive a single oral administration of a capsule containing 20 mg XEN1101 |
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| Measure | Description | Time Frame |
|---|---|---|
| Total radioactivity excreted in urine and faeces following oral administration of XEN1101 | Cumulative amount of total radioactivity excreted in urine and feces combined (CumAe(total)) and expressed as a % of the radioactive dose administered (Cum%Ae(total)) following oral administration of 14C-XEN1101 | From Screening up to Day 57 post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| 14C Metabolite profiling in of plasma, urine and feces | Chemical structure of each metabolite classified as >10% (by AUC) of total radioactivity in plasma and >10% dose excreted in urine and faeces following oral administration of XEN1101 | From Screening up to Day 57 post-dose |
| Pharmacokinetic (PK) data for 14C-XEN1101; Tmax |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Xenon Pharmaceuticals Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Sciences | Ruddington | Nottingham | NG11 6JS | United Kingdom |
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Time of maximum observed concentration for XEN1101 and metabolites in plasma and for total radioactivity in plasma and whole blood following oral administration of 14C-XEN1101 |
| From Screening up to Day 57 post-dose |
| PK data for 14C-XEN1101; Cmax | Maximum observed concentration for XEN1101 and metabolites in plasma and for total radioactivity in plasma and whole blood following oral administration of 14C-XEN1101 | From Screening up to Day 57 post-dose |
| PK data for 14C-XEN1101; T1/2 | Terminal elimination half-life for XEN1101 and metabolites in plasma and for total radioactivity in plasma and whole blood following oral administration of 14C-XEN1101 | From Screening up to Day 57 post-dose |
| Mass balance data for 14C-XEN1101 in urine | CumAe(urine)expressed as a percentage of the radioactive dose administered (Cum%Ae(urine)) | From Screening up to Day 57 post-dose |
| Mass balance data for 14C-XEN1101 in feces | CumAe(feces) expressed as a percentage of the radioactive dose administered Cum%Ae(feces) | From Screening up to Day 57 post-dose |
| Plasma whole blood concentration ratios for total radioactivity | Evaluation of whole blood:plasma concentration ratios for total radioactivity for corresponding time points | From Screening up to Day 57 post-dose |
| Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuations | From Screening up to Day 57 post-dose |