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Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of XEN1101

2017-11-17 03:41:12 | BioPortfolio

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 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.

Study Design

Conditions

Healthy Volunteers

Intervention

XPF-008, Microcrystalline Cellulose

Location

Richmond Pharmacology Ltd.
London
United Kingdom
SE1 1YR

Status

Recruiting

Source

Xenon Pharmaceuticals Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2017-11-17T03:41:12-0500

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