Clinical trial NCT03468725: Safety, Tolerability, Pharmacokinetics and Effects on Transcranial Magnetic Stimulation of Oral Doses of XEN1101
Official title: A Double-blind, Placebo-controlled Crossover Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Effects on Transcranial Magnetic Stimulation of Oral Administration of XEN1101 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Male Volunteers
Keywords: Transcranial magnetic stimulation
Lead sponsor: Xenon Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2018-03-16
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Number of participants with adverse events (AEs) as assessed by CTCAE v4.03
timeFrame: From screening (28 days prior to Day 1) through to 30 days post-final dose
measure: Resting 12-lead electrocardiogram (ECG)
timeFrame: From screening (28 days prior to Day 1) through to Day 14
measure: Number of participants with vital sign abnormalities
timeFrame: From screening (28 days prior to Day 1) through to Day 14
measure: Pharmacodynamic (PD) Effects assessed by Transcranial Magnetic Stimulation (TMS) biological markers of brain excitability
timeFrame: Day 1 predose through to Day 7
measure: PD Effects assessed by TMS biological markers of brain excitability
timeFrame: Day 1 predose through to Day 7
Secondary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Day 1 predose through to Day 8
measure: Terminal elimination half-life (t1/2)
timeFrame: Day 1 predose through to Day 8
measure: Area Under the Plasma Concentration-Time Curve from Time Zero to the Time of the Last Quantifiable Plasma Concentration (AUC0-last)
timeFrame: Day 1 predose through to Day 8
Other outcomes:
Locations:
city: Brixton
country: United Kingdom
facility: King's College Hospital
state: London
Study officials:
affiliation: Xenon Pharmaceuticals Inc.
name: Gregory Beatch, PhD
role: STUDY_DIRECTOR
References: