PK Study in Patients With Parkinson's Disease With IZD174
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|ClinicalTrials.gov Identifier: NCT04338997|
Recruitment Status : Withdrawn (Strategic decision by Sponsor)
First Posted : April 8, 2020
Last Update Posted : December 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Drug: IZD174||Phase 1|
After assessing eligibility during a screening period of up to 4 weeks, up to 6 subjects will be included.
Subjects will check into the clinic one day prior to dosing (Day -1). To evaluate and compare drug exposure levels in plasma and CSF, plasma and CSF will be serially sampled over a period of 36 hours. Subjects will be discharged from the clinic on Day 5 after all required study procedures are completed and if medically justified.
Subjects will return to the clinic approximately 1 week after discharge from the clinic for a follow-up visit.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||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|
|Estimated Study Start Date :||October 2020|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||December 2020|
Intra subject dose escalation of IZD174
Small molecule inhibitor of NLRP3
- Concentration of IZD174 in plasma [ Time Frame: Pre-dose to 36 hours post dose ]Plasma PK profile following an intra-individual dose escalation of IZD174
- Concentration of IZD174 in cerebrospinal fluid [ Time Frame: Pre-dose to 36 hours post dose ]CSF PK profile following an intra-individual dose escalation of IZD174
- Ratio of IZD174 concentration in plasma to CSF [ Time Frame: Pre-dose to 36 hours post dose ]CSF to plasma concentration ratio at each time point
- Inhibition of Interleukin-1 beta secretion in ex-vivo stimulated whole blood [ Time Frame: Pre-dose to 36 hours post dose ]Inhibition of IL-1 secretion by ex-vivo stimulated whole blood
- Incidence of Treatment-Emergent Adverse Events [ Time Frame: Day 0 to Day 10 ]Safety & Tolerability as measured by incidence if Treatment-Emergent Adverse events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04338997
|Principal Investigator:||Teus van Laar, MD, PhD||UMCG Groningen|