Healthy Volunteers
Conditions
Brief summary
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.
Interventions
DRUGXEN901
Capsule filled with XEN901
DRUGInert Ingredients Oral Product
Placebo capsule
Sponsors
Xenon Pharmaceuticals Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: * Healthy male or females aged between 18 and 55 years inclusive with a body mass index (BMI) between 18.5 and 32.0 kg/m2 * Must agree to use effective methods of contraception, if applicable * Able to swallow capsules * Able to provide written, personally signed and dated Informed Consent Form Key
Exclusion criteria
* Any history of seizures * Any current and relevant history of significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk, affect clinical or laboratory results, or the subject's ability to participate in the study * Answering yes to any of the questions within the Columbia Suicide Severity Rating Scale * Mental incapacity or language barriers precluding adequate understanding, cooperation, and compliance with the study * No prescription or over-the-counter (OTC) medications (except hormonal contraception), herbal or dietary supplements OTC medications 14 days prior to dosing to study end * No smoking 60 days prior to dosing to study end * Any clinically significant abnormalities in vital signs, ECG, physical exam, or laboratory evaluations
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events (AEs) as assessed by CTCAE v4.03 | From screening (28 days prior to Day 1) through to 30 days post-final dose | To assess AEs as a criteria of safety and tolerability |
| Resting 12-lead electrocardiogram (ECG) | At screening (28 days prior to Day 1) through to 7 days post-final dose | To assess 12-lead ECG intervals (PR, QRS, QTcF, RR) as a criteria of safety and tolerability |
| Number of participants with vital sign abnormalities | At screening (28 days prior to Day 1) through to 7 days post-final dose | To assess vital signs as a criteria of safety and tolerability |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | Day 1 predose through to 7 days post-final dose | Cmax is the maximum observed plasma concentration in ng/mL |
| Area Under the Plasma Concentration-Time Curve from Time Zero to the Time of the Last Quantifiable Plasma Concentration (AUC0-last) | Day 1 predose through to 7 days post-final dose | 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 |
| Time to the Maximum Observed Plasma Concentration (Tmax) | Day 1 predose through to 7 days post-final dose | Tmax is the time in hours to reach Cmax following dosing |
| Terminal elimination half-life (t1/2) | Day 1 predose through to 7 days post-final dose | The time in hours required for the plasma level of the study drug to decrease by one-half during the terminal elimination phase |
Countries
United Kingdom
Outcome results
None listed