Safety, Tolerability, Pharmacokinetics and Effects on Transcranial Magnetic Stimulation of Oral Doses of XEN1101

NCT03468725 | Completed Phase 1 DMC

• 3 other identifiers: XPF-008-101b2017-003181-27C17047
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The XEN1101 Phase 1 clinical trial is a randomized, double-blind, placebo-controlled study that will eventuate the safety, tolerability, pharmacokinetics (PK) and effects on transcranial magnetic stimulation (TMS) of oral doses of XEN1101 in healthy male subjects.The TMS procedure is designed to demonstrate delivery of XEN1101 into the central nervous system and to observe a change in cortical excitability as measured by EEG and/or EMG activity. It is estimated there will be approximately 15 subjects in the planned study.

Conditions

Healthy Male Volunteers

Keywords

Transcranial magnetic stimulation

Outcome Measures

Primary Outcomes (5)

• 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 ECG intervals (PR, QRS, QTcF, RR) as a criteria of safety and tolerability

  From screening (28 days prior to Day 1) through to Day 14

• Number of participants with vital sign abnormalities

  To assess vital signs as a criteria of safety and tolerability

  From screening (28 days prior to Day 1) through to Day 14

• Pharmacodynamic (PD) Effects assessed by Transcranial Magnetic Stimulation (TMS) biological markers of brain excitability

  To assess biological marker of brain excitability: amplitude (in uV) of TMS evoked potentials on the EEG

  Day 1 predose through to Day 7

• PD Effects assessed by TMS biological markers of brain excitability

  To assess biological marker of brain excitability: resting motor threshold (in %) for elicitation of an electromyographic response

  Day 1 predose through to Day 7

Secondary Outcomes (3)

• Maximum Observed Plasma Concentration (Cmax)

  Day 1 predose through to Day 8

• Terminal elimination half-life (t1/2)

  Day 1 predose through to Day 8

• 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 Day 8

Study Arms (2)

XPF-008

EXPERIMENTAL

Single oral dose

Drug: XPF-008

Placebo

ACTIVE COMPARATOR

Single oral dose

Drug: Microcrystalline Cellulose

Interventions

XPF-008 DRUG

Capsule filled with XEN1101

XPF-008

Microcrystalline Cellulose DRUG

Placebo capsule

Placebo

Eligibility Criteria

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

You may qualify if:

• Healthy male aged between 18 and 55 years inclusive with a body mass index (BMI) between 18.5 and 30.0 kg/m2
• Right-handed only
• Must agree to use effective methods of contraception, if applicable
• Able to swallow multiple capsules
• Able to provide written, personally signed and dated Informed Consent Form

You may not qualify if:

• 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
• Any clinically significant abnormalities in vital signs, ECGs, physical examinations, or laboratory evaluations
• 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 (including multivitamins, herbal or homeopathic preparations 14 days or if applicable/available, 5 half-lives prior to dosing to study end
• Any history of severe head trauma
• No smoking 60 days prior to dosing to study end

Sponsors & Collaborators

• Xenon Pharmaceuticals Inc.: lead

Study Sites (1)

King's College Hospital

Brixton, London, SE5 9RS, United Kingdom

Location

MeSH Terms

Interventions

microcrystalline cellulose

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: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2018
• First Posted: March 16, 2018
• Study Start: February 13, 2018
• Primary Completion: July 31, 2018
• Study Completion: July 31, 2018
• Last Updated: September 18, 2018

Record last verified: 2018-09

Locations

GB (1)