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This study is an evaluation of the safety and tolerability of XEN-D0103 in healthy subjects. Part 1 assesses the safety, tolerability and blood levels of the ascending single doses of XEN-D0103. Blood levels of XEN-D0103 will be assessed when administered with food and also without food in Part 2. The safety, tolerability and blood levels of XEN-D0103 will be assessed following dosing for 10 days in Part 3.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Single Ascending Dose - Cohort 1 | Experimental | 8 subjects (6 receiving 10mg XEN-D0103, 2 receiving placebo) |
|
| Part 1: Single Ascending Dose - Cohort 2 | Experimental | 8 subjects (6 receiving 30mg XEN-D0103, 2 receiving placebo) |
|
| Part 1: Single Ascending Dose - Cohort 3 | Experimental | 8 subjects (6 receiving 60mg XEN-D0103, 2 receiving placebo) |
|
| Part 1: Single Ascending Dose - Cohort 4 | Experimental | 8 subjects (6 receiving 120mg XEN-D0103, 2 receiving placebo) |
|
| Part 1: Single Ascending Dose - Cohort 5 | Experimental | 8 subjects (6 receiving 200mg XEN-D0103, 2 receiving placebo) |
|
| Part 2: Fed-Fasted |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 10mg XEN-D0103 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events | Part 1: 13 days; Part 2: 13 days; Part 3: 22 days |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under Curve (AUC) of XEN-D0103 following single and multiple dose administration | Part 1: 13 days; Part 3: 22 days | |
| Food effect on AUC of XEN-D0103 | 13 days | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON Development Solutions | Manchester | M15 6SH | United Kingdom |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| C000630294 | S66913 |
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| Experimental |
17 subjects receiving 200mg XEN-D0103 with either a high fat meal or following an overnight fast. |
|
| Part 3: Multiple Ascending Dose - Cohort 1 | Experimental | 10 subjects (8 receiving 30mg XEN-D0103 twice daily, 2 receiving placebo twice daily) |
|
| Part 3: Multiple Ascending Dose - Cohort 2 | Experimental | 10 subjects (8 receiving 60mg XEN-D0103 twice daily, 2 receiving placebo twice daily) |
|
| Part 3: Multiple Ascending Dose - Cohort 3 | Experimental | 10 subjects (8 receiving 150mg XEN-D0103 once daily, 2 receiving placebo once daily) |
|
|
| 30mg XEN-D0103 | Drug |
|
| 60mg XEN-D0103 | Drug |
|
| 120mg XEN-D0103 | Drug |
|
| 200mg XEN-D0103 | Drug |
|
| 150mg XEN-D0103 | Drug |
|
| Change in QTcF with XEN-D0103 and with placebo |
| 2 days |
| D013568 |
| Pathological Conditions, Signs and Symptoms |