Clinical trial NCT03467100: Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of XEN901
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Xenon Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2018-03-15
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants with Adverse Events (AEs) as assessed by CTCAE v4.03
timeFrame: From screening (28 days prior to Day 1) through to 30 days post-final dose
measure: Resting 12-lead electrocardiogram (ECG)
timeFrame: At screening (28 days prior to Day 1) through to 7 days post-final dose
measure: Number of participants with vital sign abnormalities
timeFrame: At screening (28 days prior to Day 1) through to 7 days post-final dose
Secondary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Day 1 predose through to 7 days post-final dose
measure: Time to the Maximum Observed Plasma Concentration (Tmax)
timeFrame: Day 1 predose through to 7 days post-final dose
measure: Terminal elimination half-life (t1/2)
timeFrame: Day 1 predose through to 7 days post-final dose
measure: Area Under the Plasma Concentration-Time Curve from Time Zero to the Time of the Last Quantifiable Plasma Concentration (AUC0-last)
timeFrame: Day 1 predose through to 7 days post-final dose
Other outcomes:
Locations:
city: Ruddington
country: United Kingdom
facility: Quotient Sciences
Study officials:
affiliation: Xenon Pharmaceuticals Inc.
name: Gregory Beatch, PhD
role: STUDY_DIRECTOR
References: