Status:
COMPLETED
Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of XEN901
Lead Sponsor:
Xenon Pharmaceuticals Inc.
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
February 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 19 2018
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03467100
Start Date
February 19 2018
End Date
December 19 2018
Last Update
July 22 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Quotient Sciences
Ruddington, United Kingdom, NG11 6JS