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Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of XEN1101

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ClinicalTrials.gov Identifier: NCT03340220
Recruitment Status : Recruiting
First Posted : November 13, 2017
Last Update Posted : June 29, 2018
Sponsor:
Information provided by (Responsible Party):
Xenon Pharmaceuticals Inc.

Study Description
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Brief Summary:
The XEN1101 Phase 1 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the safety, tolerability and PK of both single ascending doses (SAD) and multiple ascending doses (MAD) of XEN1101 in healthy subjects. In addition to safety and PK data, the clinical trial has been designed to include a pharmacodynamic read-out by incorporating a pilot transcranial magnetic stimulation (TMS) sub-study. The TMS model sub-study 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 64 subjects in the planned SAD and MAD cohorts.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: XPF-008 Drug: Microcrystalline Cellulose Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Phase 1, First-in-human, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and PK of Single and Multiple Ascending Oral Doses of XEN1101 and Preliminary Open-label Pharmacodynamic Assessment in Healthy Subjects
Actual Study Start Date : October 16, 2017
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: XPF-008

Single ascending dose: Single oral dose for each cohort

Multiple ascending dose: 7 days of single oral dose daily for each cohort

 Drug: XPF-008
Capsule filled with XEN1101
Placebo Comparator: Placebo - Microcrystalline cellulose

Single Ascending Dose: Single oral dose for each cohort

Multiple Ascending Dose: 7 days of single oral dose daily for each cohort

 Drug: Microcrystalline Cellulose
Placebo capsule


Outcome Measures
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Primary Outcome Measures :
  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 electrocardiogram (ECG) [ Time Frame: At screening (28 days prior to Day 1) through to 7 days post-final dose ]
    To assess ECG as a criteria of safety and tolerability

  3. Vital signs [ Time Frame: At screening (28 days prior to Day 1) through to 7 days post-final dose ]
    To assess vital signs as a criteria of safety and tolerability


Secondary Outcome Measures :
  1. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Day 1 predose through to 7 days post-final dose ]
    Cmax is the maximum observed plasma concentration in ng/mL

  2. Time to the Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Day 1 predose through to 7 days post-final dose ]
    Tmax is the time in hours to reach Cmax following dosing

  3. Terminal elimination half-life (t1/2) [ Time Frame: Day 1 predose through to 7 days post-final dose ]
    The time in hours required for the plasma level of the study drug to decrease by one-half during the terminal elimination phase

  4. 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 7 days post-final dose ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Key Inclusion Criteria:

  • Healthy male or females aged between 18 and 55 years inclusive with a body mass index (BMI) between 18.50 and 30.00 kg/m2
  • Must agree to use effective methods of contraception, if applicable
  • Able to swallow capsules
  • Able to provide written, personally signed and dated ICF

Key Exclusion Criteria:

  • Any history of epileptic seizures
  • 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
  • Answering "yes" to any of the questions within the Columbia Suicide Severity Rating Scale
  • Mental incapacity or lingual barriers precluding adequate understanding, cooperation, and compliance with the study
  • No prescription or over-the-counter (OTC) medications (except hormonal contraception), herbal or dietary supplements OTC medications 14 days prior to dosing to study end
  • No smoking 60 days prior to dosing to study end
  • No soft drugs 3 months prior to Screening and hard drugs 2 years prior to Screening
Contacts and Locations
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Information from the National Library of Medicine

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): NCT03340220


Contacts
Contact: C. Leung 1 604 484 3300 cleung@xenon-pharma.com

Locations
United Kingdom
Richmond Pharmacology Ltd. Recruiting
London, United Kingdom, SE1 1YR
Principal Investigator: Jorg Taubel, MD FFPM         
King's College Hospital Recruiting
London, United Kingdom, SE5 9RS
Principal Investigator: Mark Richardson, MA PhD FRCP         
Sponsors and Collaborators
Xenon Pharmaceuticals Inc.
Investigators
Study Director: Gregory N Beatch, PhD Xenon Pharmaceuticals Inc.
More Information
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Responsible Party: Xenon Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT03340220     History of Changes
Other Study ID Numbers: XPF-008-101a
2017-003168-11 ( EudraCT Number )
C17030 ( Other Identifier: Richmond Pharmacology Ltd )
First Posted: November 13, 2017    Key Record Dates
Last Update Posted: June 29, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xenon Pharmaceuticals Inc.:
Transcranial Magnetic Stimulation