- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03467100
Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of XEN901
July 18, 2019 updated by: Xenon Pharmaceuticals Inc.
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
70
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ruddington, United Kingdom, NG11 6JS
- Quotient Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
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
|
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
|
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
Time Frame: From screening (28 days prior to Day 1) through to 30 days post-final dose
|
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)
Time Frame: At screening (28 days prior to Day 1) through to 7 days post-final dose
|
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
Time Frame: At screening (28 days prior to Day 1) through to 7 days post-final dose
|
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)
Time Frame: Day 1 predose through to 7 days post-final dose
|
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)
Time Frame: Day 1 predose through to 7 days post-final dose
|
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)
Time Frame: Day 1 predose through to 7 days post-final dose
|
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)
Time Frame: Day 1 predose through to 7 days post-final dose
|
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
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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