drugset / Trial / NCT03468725

Safety, Tolerability, Pharmacokinetics and Effects on Transcranial Magnetic Stimulation of Oral Doses of XEN1101

NCT03468725 ↗

Phase 1 Completed 20 enrolled Xenon Pharmaceuticals Inc.
RandomizedCrossoverTriple-blindTreatment

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 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.

Timeline

Start
2018-02-13
Primary completion
2018-07-31
Completion
2018-07-31

Outcome

Met primary endpoint

release “XEN1101 Demonstrates Statistically Significant Reduction in Corticospinal and Cortical Excitability as Measured by TMS-EMG and TMS-EEG” xenon-pharma.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Azetukalner Small molecule — Oral

Indications

No indication recorded.