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Completed

NCT Number: NCT03468725

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

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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Key information

Conditions

Healthy Male Volunteers

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

King's College Hospital

Brixton, London, SE5 9RS, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

XPF-008

Drug

Capsule filled with XEN1101

Microcrystalline Cellulose

Drug

Placebo capsule

Primary outcomes

  1. Number of participants with adverse events (AEs) as assessed by CTCAE v4.03

    Time frame: 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

  2. Resting 12-lead electrocardiogram (ECG)

    Time frame: 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

  3. Number of participants with vital sign abnormalities

    Time frame: From screening (28 days prior to Day 1) through to Day 14

    To assess vital signs as a criteria of safety and tolerability

  4. Pharmacodynamic (PD) Effects assessed by Transcranial Magnetic Stimulation (TMS) biological markers of brain excitability

    Time frame: Day 1 predose through to Day 7

    To assess biological marker of brain excitability: amplitude (in uV) of TMS evoked potentials on the EEG

  5. PD Effects assessed by TMS biological markers of brain excitability

    Time frame: Day 1 predose through to Day 7

    To assess biological marker of brain excitability: resting motor threshold (in %) for elicitation of an electromyographic response

Secondary outcomes

  1. Maximum Observed Plasma Concentration (Cmax)

    Time frame: Day 1 predose through to Day 8

    Cmax is the maximum observed plasma concentration in ng/mL

  2. Terminal elimination half-life (t1/2)

    Time frame: 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

  3. Area Under the Plasma Concentration-Time Curve from Time Zero to the Time of the Last Quantifiable Plasma Concentration (AUC0-last)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Xenon Pharmaceuticals Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 16, 2018
Registry last updated
Sep 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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