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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: XEN901; Drug: Inert Ingredients Oral Product

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Ruddington, United Kingdom, NG11 6JS
    • Quotient Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Resting 12-lead electrocardiogram (ECG)	To assess 12-lead ECG intervals (PR, QRS, QTcF, RR) as a criteria of safety and tolerability	At screening (28 days prior to Day 1) through to 7 days post-final dose
Number of participants with vital sign abnormalities	To assess vital signs as a criteria of safety and tolerability	At screening (28 days prior to Day 1) through to 7 days post-final dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Observed Plasma Concentration (Cmax)	Cmax is the maximum observed plasma concentration in ng/mL	Day 1 predose through to 7 days post-final dose
Time to the Maximum Observed Plasma Concentration (Tmax)	Tmax is the time in hours to reach Cmax following dosing	Day 1 predose through to 7 days post-final dose
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 7 days post-final dose
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 7 days post-final dose

Collaborators and Investigators

• Sponsor: Xenon Pharmaceuticals Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 19, 2018
• Primary Completion (ACTUAL): December 19, 2018
• Study Completion (ACTUAL): December 19, 2018

Study Registration Dates

• First Submitted: March 2, 2018
• First Submitted That Met QC Criteria: March 14, 2018
• First Posted (ACTUAL): March 15, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 22, 2019
• Last Update Submitted That Met QC Criteria: July 18, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: XPF-006-101; 2017-004046-26 (EUDRACT_NUMBER); QCL118145 (OTHER: Quotient Sciences Study Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No