Healthy Male Volunteers
Conditions
Keywords
Transcranial magnetic stimulation
Brief summary
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.
Interventions
DRUGXPF-008
Capsule filled with XEN1101
DRUGMicrocrystalline Cellulose
Placebo capsule
Sponsors
Xenon Pharmaceuticals Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: * Healthy male aged between 18 and 55 years inclusive with a body mass index (BMI) between 18.5 and 30.0 kg/m2 * Right-handed only * Must agree to use effective methods of contraception, if applicable * Able to swallow multiple capsules * Able to provide written, personally signed and dated Informed Consent Form Key
Exclusion criteria
* 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 * Any clinically significant abnormalities in vital signs, ECGs, physical examinations, or laboratory evaluations * 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 (including multivitamins, herbal or homeopathic preparations 14 days or if applicable/available, 5 half-lives prior to dosing to study end * Any history of severe head trauma * No smoking 60 days prior to dosing to study end
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PD Effects assessed by TMS biological markers of brain excitability | Day 1 predose through to Day 7 | To assess biological marker of brain excitability: resting motor threshold (in %) for elicitation of an electromyographic response |
| Resting 12-lead electrocardiogram (ECG) | From screening (28 days prior to Day 1) through to Day 14 | To assess ECG intervals (PR, QRS, QTcF, RR) as a criteria of safety and tolerability |
| Number of participants with vital sign abnormalities | From screening (28 days prior to Day 1) through to Day 14 | To assess vital signs as a criteria of safety and tolerability |
| Pharmacodynamic (PD) Effects assessed by Transcranial Magnetic Stimulation (TMS) biological markers of brain excitability | Day 1 predose through to Day 7 | To assess biological marker of brain excitability: amplitude (in uV) of TMS evoked potentials on the EEG |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Terminal elimination half-life (t1/2) | Day 1 predose through to Day 8 | The time in hours required for the plasma level of the study drug to decrease by one-half during the terminal elimination phase |
| 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 Day 8 | 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 |
| Maximum Observed Plasma Concentration (Cmax) | Day 1 predose through to Day 8 | Cmax is the maximum observed plasma concentration in ng/mL |
Countries
United Kingdom
Outcome results
None listed