MEAK

Brief description of study

Primary: to evaluate the safety and tolerability of single doses of AUT00201 in patients with MEAK. Secondary:
-To characterize the correlation of exposure to AUT00201 with effects on measures of cortical inhibition, as assessed by paired-pulse transcranial magnetic stimulation (TMS), in patients with MEAK -To assess the pharmacokinetic (PK) profile of AUT00201 after single doses of AUT00201 in patients with MEAK.
Exploratory endpoints are listed in the protocol. The primary endpoint is safety and tolerability of single doses of AUT00201 in patients with MEAK. Specifically, -Change from baseline in laboratory assessments (routine hematology, biochemistry, and urinalysis) -Incidence of clinically significant laboratory findings -Change from baseline in vital signs
-Change from baseline physical examination findings 24 hours after investigational product (IP) administration -Change from baseline in 12-lead ECG findings -Incidence of AEs
-Change from baseline in safety EEG parameters. The secondary outcome variables/endpoints are: 1) Change from baseline in cortical inhibition as assessed with paired-pulse TMS (EMG), specifically: a. SICI as measured by paired-pulse TMS b. LICI as measured by paired-pulse TMS c. Cortical gain function as measured by paired-pulse TMS. 2) PK parameters following single doses of AUT00201: Cmax and area under the plasma concentration-time curve from time zero to 24 hours (AUC24) of AUT00201. Exploratory endpoints are noted in the protocol.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Medical Research
  • Age: - 99 Years
  • Gender: All

TBD

Updated on 09 Mar 2024. Study ID: 852682
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Interested in the study

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