Healthy Male Volunteers | Safety, Tolerability, Pharmacokinetics and Effects on Transcranial Magnetic Stimulation of Oral Doses of XEN1101
Healthy Male Volunteers research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Healthy Male Volunteers
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:XPF-008Capsule filled with XEN1101
Drug:Microcrystalline CellulosePlacebo capsule
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
XPF-008Single oral dose
PlaceboSingle oral dose
Start Date: February 13, 2018
Completed Date: July 2018
Phase: Phase 1
Primary Outcome: Number of participants with adverse events (AEs) as assessed by CTCAE v4.03
Secondary Outcome: Maximum Observed Plasma Concentration (Cmax)
Study sponsors, principal investigator, and references
Principal Investigator: Gregory Beatch, PhD
Lead Sponsor: Xenon Pharmaceuticals Inc.