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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-13

Study Completion Date

2018-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Male Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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XPF-008

Single oral dose

Group Type EXPERIMENTAL

XPF-008

Intervention Type DRUG

Capsule filled with XEN1101

Placebo

Single oral dose

Group Type ACTIVE_COMPARATOR

Microcrystalline Cellulose

Intervention Type DRUG

Placebo capsule

Interventions

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XPF-008

Capsule filled with XEN1101

Intervention Type DRUG

Microcrystalline Cellulose

Placebo capsule

Intervention Type DRUG

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes