Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of XEN1101
Unknown status
Xenon Pharmaceuticals Inc.
Phase 1
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 ascending doses (MAD) of XEN1101 in healthy subjects. In addition to safety and PK
data, the clinical trial has been designed to include a pharmacodynamic read-out by
incorporating a pilot transcranial magnetic stimulation (TMS) sub-study. The TMS model
sub-study is designed to demonstrate delivery of XEN1101 into the central nervous system and
to observe a change in cortical excitability as measured by EEG and/or EMG activity. It is
estimated there will be approximately 64 subjects in the planned SAD and MAD cohorts.
Safety, Tolerability, Pharmacokinetics and Effects on Transcranial Magnetic Stimulation of Oral Doses of XEN1101
Completed
Xenon Pharmaceuticals Inc.
Phase 1
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 stimulation (TMS) of oral doses of XEN1101 in healthy male subjects.The
TMS procedure is designed to demonstrate delivery of XEN1101 into the central nervous system
and to observe a change in cortical excitability as measured by EEG and/or EMG activity. It
is estimated there will be approximately 15 subjects in the planned study.
A Study to Evaluate XEN1101 as Adjunctive Therapy in Focal Epilepsy
Active, not recruiting
NCGS, Inc.
Phase 2
The XEN1101 Phase 2 clinical trial is a randomized, double-blind, placebo-controlled study
that will evaluate the clinical efficacy, safety and tolerability of increasing doses of
XEN1101 administered as adjunctive treatment in adult patients diagnosed with focal epilepsy,
followed by an optional open-label extension (OLE).
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