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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03468725
Other study ID # XPF-008-101b
Secondary ID 2017-003181-27C1
Status Completed
Phase Phase 1
First received
Last updated
Start date February 13, 2018
Est. completion date July 31, 2018

Study information

Verified date September 2018
Source Xenon Pharmaceuticals Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date July 31, 2018
Est. primary completion date July 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 55 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
XPF-008
Capsule filled with XEN1101
Microcrystalline Cellulose
Placebo capsule

Locations

Country Name City State
United Kingdom King's College Hospital Brixton London

Sponsors (1)

Lead Sponsor Collaborator
Xenon Pharmaceuticals Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants with adverse events (AEs) as assessed by CTCAE v4.03 To assess AEs as a criteria of safety and tolerability From screening (28 days prior to Day 1) through to 30 days post-final dose
Primary Resting 12-lead electrocardiogram (ECG) To assess ECG intervals (PR, QRS, QTcF, RR) as a criteria of safety and tolerability From screening (28 days prior to Day 1) through to Day 14
Primary Number of participants with vital sign abnormalities To assess vital signs as a criteria of safety and tolerability From screening (28 days prior to Day 1) through to Day 14
Primary Pharmacodynamic (PD) Effects assessed by Transcranial Magnetic Stimulation (TMS) biological markers of brain excitability To assess biological marker of brain excitability: amplitude (in uV) of TMS evoked potentials on the EEG Day 1 predose through to Day 7
Primary PD Effects assessed by TMS biological markers of brain excitability To assess biological marker of brain excitability: resting motor threshold (in %) for elicitation of an electromyographic response Day 1 predose through to Day 7
Secondary Maximum Observed Plasma Concentration (Cmax) Cmax is the maximum observed plasma concentration in ng/mL Day 1 predose through to Day 8
Secondary Terminal elimination half-life (t1/2) The time in hours required for the plasma level of the study drug to decrease by one-half during the terminal elimination phase Day 1 predose through to Day 8
Secondary Area Under the Plasma Concentration-Time Curve from Time Zero to the Time of the Last Quantifiable Plasma Concentration (AUC0-last) 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 Day 1 predose through to Day 8
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