An open-label Phase 1b study to evaluate the pharmacokinetics and pharmacodynamics in plasma and cerebrospinal fluid (CSF), safety and tolerability of oral IZD174 in patients with Parkinson*s Disease.
- Conditions
- Parkinson's Disease10028037
- Registration Number
- NL-OMON49465
- Lead Sponsor
- Inflazome Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6
The subject is a man or woman aged between 45 and 69, inclusive.
Documented clinically established diagnosis of Parkinson*s Disease, Hoehn &
Yahr stage 1 to 3 and Montreal Cognitive Assessment greater or equal than 26.
Diagnosis of Parkinson*s Disease consistent with MDS Research Criteria for the
Diagnosis of Parkinson*s Disease must include bradykinesia with sequence
effect, and motor asymmetry (especially if no rest tremor). Diagnosis has to be
made less than 3 years prior to Screening.
Patients that receive treatment for Parkinson*s Disease should be on a stable
dose level and regimen for at least 14 days prior to study drug administration
and should have the intention to stay on this regimen throughout the study.
The subject understands the nature and purpose of the study, including possible
risks and side effects, and is willing and able to comply with all compulsory
study procedures and provides signed and dated written informed consent (in
accordance with local regulations) prior to any study procedures being
performed.
The subject used any NSAIDs, steroids, colchicine or anti-IL-1 inhibitors
within 7 days prior to Day 1.
The subject received any investigational drugs within 4 weeks or 5 half-lives
(whichever is longer), prior to Day 1.
The subject had an active systemic infection (other than common cold) within 2
weeks prior to Day 1.
The subject has a history of severe hypersensitivity to previous drugs.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The following ratios will be derived to evaluate to which extent IZD174<br /><br>penetrates into the brain:<br /><br>CSF to plasma concentration ratios (CCSF:Cp) at each time point;<br /><br>CSF to plasma AUC ratio for each dose level (AUC0-8,CSF/AUC0-8,plasma and<br /><br>AUC0-t,CSF/AUC0-t,plasma [for the 3rd dose only]) and within three dose levels<br /><br>(AUC0-t,CSF/AUC0-t,plasma).<br /><br>The following are defined as Plasma and CSF PK parameters for IZD174 within<br /><br>three dose levels (calculated using a non-compartmental model): Maximum<br /><br>concentration (Cmax);<br /><br>Time to Cmax (Tmax);<br /><br>Area under the concentration-time curve (AUC) from time of 1st dosing (zero) to<br /><br>time t of the last measured concentration above the limit of quantification<br /><br>(AUC0-t);<br /><br>Area under the concentration-time curve from time of 1st dosing (zero) to<br /><br>infinity (AUC0-inf);<br /><br>Total body clearance (CL/F) and volume of distribution (Vz/F).</p><br>
- Secondary Outcome Measures
Name Time Method <p>The PD parameter NLRP3 inhibition in whole blood (ex vivo stimulated).<br /><br>Safety parameters include AEs, physical examination, neurological examination,<br /><br>clinical laboratory values, vital signs, and 12-lead ECG.</p><br>