Status:
COMPLETED
Safety, Tolerability, Pharmacokinetics and Effects on Transcranial Magnetic Stimulation of Oral Doses of XEN1101
Lead Sponsor:
Xenon Pharmaceuticals Inc.
Conditions:
Healthy Male Volunteers
Eligibility:
MALE
18-55 years
Phase:
PHASE1
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 stim...
Eligibility Criteria
Inclusion
- Key
- 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
- Key
Exclusion
- 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
Key Trial Info
Start Date :
February 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2018
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03468725
Start Date
February 13 2018
End Date
July 31 2018
Last Update
September 18 2018
Active Locations (1)
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1
King's College Hospital
Brixton, London, United Kingdom, SE5 9RS