Safety, Tolerability, Pharmacokinetics and Effects on Transcranial Magnetic Stimulation of Oral Doses of XEN1101

Xenon Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Male Volunteers

Treatments: Drug: XPF-008; Drug: Microcrystalline Cellulose

Study type: Interventional

Funder types: Industry

Identifiers

NCT03468725

XPF-008-101b

2017-003181-27 (EudraCT Number)

C17047 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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20 participants in 2 patient groups

XPF-008

Experimental group

Description:

Single oral dose

Treatment:

Drug: XPF-008

Placebo

Active Comparator group

Description:

Single oral dose

Treatment:

Drug: Microcrystalline Cellulose