Back to resultsPK Study in Patients With Parkinson's Disease With IZD174
Primary Purpose
Parkinson Disease
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
IZD174
Sponsored by
About this trial
This is an interventional basic science trial for Parkinson Disease
Eligibility Criteria
Inclusion Criteria:
- The subject is a man or woman aged between 45 and 75, 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 wit 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.
- The subject understands the nature and purpose of the study, including possible risks and side effects, and i willing and able to comply with all compulsory stud procedures and provides signed and dated written informed consent (in accordance with local regulations) prior to any study procedures being performed.
Exclusion Criteria:
- 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.
- The subject has any severe, progressive or uncontrolled medical condition at Screening or on Day -1 that in the judgment of the investigator prevents the subject from participating in the study.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IZD174
Arm Description
Intra subject dose escalation of IZD174
Outcomes
Primary Outcome Measures
Concentration of IZD174 in plasma
Plasma PK profile following an intra-individual dose escalation of IZD174
Concentration of IZD174 in cerebrospinal fluid
CSF PK profile following an intra-individual dose escalation of IZD174
Ratio of IZD174 concentration in plasma to CSF
CSF to plasma concentration ratio at each time point
Secondary Outcome Measures
Inhibition of Interleukin-1 beta secretion in ex-vivo stimulated whole blood
Inhibition of IL-1 secretion by ex-vivo stimulated whole blood
Incidence of Treatment-Emergent Adverse Events
Safety & Tolerability as measured by incidence if Treatment-Emergent Adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04338997
Brief Title
PK Study in Patients With Parkinson's Disease With IZD174
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Strategic decision by Sponsor
Study Start Date
October 2020 (Anticipated)
Primary Completion Date
November 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inflazome UK Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Single center, open-label, intra-individual dose-escalation study in subjects with mild/moderate Parkinson's Disease
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IZD174
Arm Type
Experimental
Arm Description
Intra subject dose escalation of IZD174
Intervention Type
Drug
Intervention Name(s)
IZD174
Intervention Description
Small molecule inhibitor of NLRP3
Primary Outcome Measure Information:
Title
Concentration of IZD174 in plasma
Description
Plasma PK profile following an intra-individual dose escalation of IZD174
Time Frame
Pre-dose to 36 hours post dose
Title
Concentration of IZD174 in cerebrospinal fluid
Description
CSF PK profile following an intra-individual dose escalation of IZD174
Time Frame
Pre-dose to 36 hours post dose
Title
Ratio of IZD174 concentration in plasma to CSF
Description
CSF to plasma concentration ratio at each time point
Time Frame
Pre-dose to 36 hours post dose
Secondary Outcome Measure Information:
Title
Inhibition of Interleukin-1 beta secretion in ex-vivo stimulated whole blood
Description
Inhibition of IL-1 secretion by ex-vivo stimulated whole blood
Time Frame
Pre-dose to 36 hours post dose
Title
Incidence of Treatment-Emergent Adverse Events
Description
Safety & Tolerability as measured by incidence if Treatment-Emergent Adverse events
Time Frame
Day 0 to Day 10
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The subject is a man or woman aged between 45 and 75, 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 wit 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.
The subject understands the nature and purpose of the study, including possible risks and side effects, and i willing and able to comply with all compulsory stud procedures and provides signed and dated written informed consent (in accordance with local regulations) prior to any study procedures being performed.
Exclusion Criteria:
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.
The subject has any severe, progressive or uncontrolled medical condition at Screening or on Day -1 that in the judgment of the investigator prevents the subject from participating in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teus van Laar, MD, PhD
Organizational Affiliation
UMCG Groningen
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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PK Study in Patients With Parkinson's Disease With IZD174
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