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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-004046-26 | EudraCT Number | ||
| QCL118145 | Other Identifier | Quotient Sciences Study Number |
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The XEN901 Phase 1 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the safety, tolerability and pharmacokinetics (PK) of both single ascending doses (SAD) and multiple ascending doses (MAD) of XEN901 in healthy subjects. It is estimated there will be approximately 64 subjects in the planned SAD and MAD cohorts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XEN901 | Experimental | Single ascending dose: Single oral dose for each cohort; Multiple ascending dose: 7 days of single oral dose twice daily for each cohort |
|
| Placebo | Placebo Comparator | Single Ascending Dose: Single oral dose for each cohort; Multiple Ascending Dose: 7 days of single oral dose twice daily for each cohort |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XEN901 | Drug | Capsule filled with XEN901 |
| |
| Inert Ingredients Oral Product |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) as assessed by CTCAE v4.03 | To assess AEs as a criteria of safety and tolerability | From screening (28 days prior to Day 1) through to 30 days post-final dose |
| Resting 12-lead electrocardiogram (ECG) | To assess 12-lead ECG intervals (PR, QRS, QTcF, RR) as a criteria of safety and tolerability | At screening (28 days prior to Day 1) through to 7 days post-final dose |
| Number of participants with vital sign abnormalities | To assess vital signs as a criteria of safety and tolerability | At screening (28 days prior to Day 1) through to 7 days post-final dose |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | Cmax is the maximum observed plasma concentration in ng/mL | Day 1 predose through to 7 days post-final dose |
| Time to the Maximum Observed Plasma Concentration (Tmax) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory Beatch, PhD | Xenon Pharmaceuticals Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Sciences | Ruddington | NG11 6JS | United Kingdom |
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| Drug |
Placebo capsule |
|
Tmax is the time in hours to reach Cmax following dosing
| Day 1 predose through to 7 days post-final dose |
| Terminal elimination half-life (t1/2) | The time in hours required for the plasma level of the study drug to decrease by one-half during the terminal elimination phase | Day 1 predose through to 7 days post-final dose |
| Area Under the Plasma Concentration-Time Curve from Time Zero to the Time of the Last Quantifiable Plasma Concentration (AUC0-last) | The area under the plasma concentration-time curve [in ng.h/mL] from time zero to the time corresponding to the last quantifiable plasma concentration | Day 1 predose through to 7 days post-final dose |