Status:
COMPLETED
Safety, Tolerability, and Pharmacokinetics (PK) of Single and Multiple Ascending Oral Doses of XEN1101.
Lead Sponsor:
Xenon Pharmaceuticals Inc.
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The XEN1101 Phase 1 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the safety, tolerability and PK of both single ascending doses (SAD) and multiple ascendin...
Detailed Description
Part 1 will study safety, tolerability, PK of single ascending doses (SAD) of XPF-008 as well as the impact and variability of single ascending doses of XPF-008 on TMS. Part 2 will study the safety, ...
Eligibility Criteria
Inclusion
- Key
- Healthy male or females aged between 18 and 55 years inclusive with a body mass index (BMI) between 18.50 and 30.00 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 (ICF)
- Key
Exclusion
- Any history of epileptic 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 lingual 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
- No soft drugs 3 months prior to Screening and hard drugs 2 years prior to Screening
Key Trial Info
Start Date :
November 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 26 2021
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT03340220
Start Date
November 13 2017
End Date
November 26 2021
Last Update
May 11 2023
Active Locations (1)
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1
Richmond Pharmacology Ltd.
London, United Kingdom, SE1 1YR