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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03467100
• Other study ID #: XPF-006-101
• Secondary ID: 2017-004046-26QC
• Status: Completed
• Phase: Phase 1
• Start date: February 19, 2018
• Est. completion date: December 19, 2018

Study information

• Verified date: July 2019
• Source: Xenon Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 19, 2018
• Est. primary completion date: December 19, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• XEN901
Capsule filled with XEN901
• Inert Ingredients Oral Product
Placebo capsule

Locations

Country	Name	City	State
United Kingdom	Quotient Sciences	Ruddington

Sponsors (1)

Lead Sponsor	Collaborator
Xenon Pharmaceuticals Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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