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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-003181-27 | EudraCT Number | ||
| C17047 | Other Identifier | Richmond Pharmacology's Study Code |
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The XEN1101 Phase 1 clinical trial is a randomized, double-blind, placebo-controlled study that will eventuate the safety, tolerability, pharmacokinetics (PK) and effects on transcranial magnetic stimulation (TMS) of oral doses of XEN1101 in healthy male subjects.The TMS procedure is designed to demonstrate delivery of XEN1101 into the central nervous system and to observe a change in cortical excitability as measured by EEG and/or EMG activity. It is estimated there will be approximately 15 subjects in the planned study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XPF-008 | Experimental | Single oral dose |
|
| Placebo | Active Comparator | Single oral dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XPF-008 | Drug | Capsule filled with XEN1101 |
| |
| Microcrystalline Cellulose |
| 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 ECG intervals (PR, QRS, QTcF, RR) as a criteria of safety and tolerability | From screening (28 days prior to Day 1) through to Day 14 |
| Number of participants with vital sign abnormalities | To assess vital signs as a criteria of safety and tolerability | From screening (28 days prior to Day 1) through to Day 14 |
| Pharmacodynamic (PD) Effects assessed by Transcranial Magnetic Stimulation (TMS) biological markers of brain excitability | To assess biological marker of brain excitability: amplitude (in uV) of TMS evoked potentials on the EEG | Day 1 predose through to Day 7 |
| PD Effects assessed by TMS biological markers of brain excitability | To assess biological marker of brain excitability: resting motor threshold (in %) for elicitation of an electromyographic response | Day 1 predose through to Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | Cmax is the maximum observed plasma concentration in ng/mL | Day 1 predose through to Day 8 |
| 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 |
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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 |
|---|---|---|---|---|---|---|
| King's College Hospital | Brixton | London | SE5 9RS | United Kingdom |
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| ID | Term |
|---|---|
| C109691 | microcrystalline cellulose |
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| Drug |
Placebo capsule |
|
| Day 1 predose through to Day 8 |
| 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 Day 8 |