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

NCT03467100 | Completed Phase 1 DMC

• 3 other identifiers: XPF-006-1012017-004046-26QCL118145
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Maximum Observed Plasma Concentration (Cmax)

  Day 1 predose through to 7 days post-final dose

• Time to the Maximum Observed Plasma Concentration (Tmax)

  Day 1 predose through to 7 days post-final dose

• Terminal elimination half-life (t1/2)

  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)

  Day 1 predose through to 7 days post-final dose

Study Arms (2)

XEN901

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

XEN901 DRUG

Capsule filled with XEN901

XEN901

Inert Ingredients Oral Product DRUG

Placebo capsule

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xenon Pharmaceuticals Inc.: lead

Study Sites (1)

Quotient Sciences

Ruddington, NG11 6JS, United Kingdom

Location

Study Officials

• Gregory Beatch, PhD

  Xenon Pharmaceuticals Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2018
• First Posted: March 15, 2018
• Study Start: February 19, 2018
• Primary Completion: December 19, 2018
• Study Completion: December 19, 2018
• Last Updated: July 22, 2019

Record last verified: 2019-07

Locations

GB (1)