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Completed

NCT Number: NCT03467100

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Quotient Sciences

Ruddington, NG11 6JS, 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 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

Treatment and study plan

XEN901

Drug

Capsule filled with XEN901

Inert Ingredients Oral Product

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: 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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Xenon Pharmaceuticals Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 15, 2018
Registry last updated
Jul 22, 2019

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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