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Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of XEN901

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ClinicalTrials.gov Identifier: NCT03467100
Recruitment Status : Recruiting
First Posted : March 15, 2018
Last Update Posted : March 15, 2018
Sponsor:
Information provided by (Responsible Party):
Xenon Pharmaceuticals Inc.

Brief Summary:
The XEN901 Phase 1 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the safety, tolerability and pharmacokinetics (PK) of both single ascending doses (SAD) and multiple ascending doses (MAD) of XEN901 in healthy subjects. 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: XEN901 Drug: Inert Ingredients Oral Product Phase 1

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, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of XEN901 in Healthy Subjects
Actual Study Start Date : February 19, 2018
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Arm Intervention/treatment
Experimental: XEN901
Single ascending dose: Single oral dose for each cohort; Multiple ascending dose: 7 days of single oral dose twice daily for each cohort
Drug: XEN901
Capsule filled with XEN901

Placebo Comparator: Placebo
Single Ascending Dose: Single oral dose for each cohort; Multiple Ascending Dose: 7 days of single oral dose twice daily for each cohort
Drug: Inert Ingredients Oral Product
Placebo capsule




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 12-lead electrocardiogram (ECG) [ Time Frame: At screening (28 days prior to Day 1) through to 7 days post-final dose ]
    To assess 12-lead ECG intervals (PR, QRS, QTcF, RR) as a criteria of safety and tolerability

  3. Number of participants with vital sign abnormalities [ 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



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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 18.5 and 32.0 kg/m2
  • Must agree to use effective methods of contraception, if applicable
  • Able to swallow capsules
  • Able to provide written, personally signed and dated Informed Consent Form

Key Exclusion Criteria:

  • Any history of 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 language 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
  • Any clinically significant abnormalities in vital signs, ECG, physical exam, or laboratory evaluations

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): NCT03467100


Contacts
Contact: Lena Legkaia, BSc 1 604 484 3308 llegkaia@xenon-pharma.com

Locations
United Kingdom
Quotient Sciences Recruiting
Ruddington, United Kingdom, NG11 6JS
Principal Investigator: Sharan Sidhu, MBChB BAO         
Sponsors and Collaborators
Xenon Pharmaceuticals Inc.
Investigators
Study Director: Gregory Beatch, PhD Xenon Pharmaceuticals Inc.

Responsible Party: Xenon Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT03467100     History of Changes
Other Study ID Numbers: XPF-006-101
2017-004046-26 ( EudraCT Number )
QCL118145 ( Other Identifier: Quotient Sciences Study Number )
First Posted: March 15, 2018    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: March 2018

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