Safety, Tolerability, Pharmacokinetics and Effects on Transcranial Magnetic Stimulation of Oral Doses of XEN1101
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ClinicalTrials.gov Identifier: NCT03468725 |
Recruitment Status :
Completed
First Posted : March 16, 2018
Last Update Posted : September 18, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy Male Volunteers | Drug: XPF-008 Drug: Microcrystalline Cellulose | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official 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 |
Actual Study Start Date : | February 13, 2018 |
Actual Primary Completion Date : | July 31, 2018 |
Actual Study Completion Date : | July 31, 2018 |
Arm | Intervention/treatment |
---|---|
Experimental: XPF-008
Single oral dose
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Drug: XPF-008
Capsule filled with XEN1101 |
Active Comparator: Placebo
Single oral dose
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Drug: Microcrystalline Cellulose
Placebo capsule |
- 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
- 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
- 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
- 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
- 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
- Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Day 1 predose through to Day 8 ]Cmax is the maximum observed plasma concentration in ng/mL
- 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
- 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

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03468725
United Kingdom | |
King's College Hospital | |
Brixton, London, United Kingdom, SE5 9RS |
Study Director: | Gregory Beatch, PhD | Xenon Pharmaceuticals Inc. |
Responsible Party: | Xenon Pharmaceuticals Inc. |
ClinicalTrials.gov Identifier: | NCT03468725 |
Other Study ID Numbers: |
XPF-008-101b 2017-003181-27 ( EudraCT Number ) C17047 ( Other Identifier: Richmond Pharmacology's Study Code ) |
First Posted: | March 16, 2018 Key Record Dates |
Last Update Posted: | September 18, 2018 |
Last Verified: | September 2018 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Transcranial magnetic stimulation |