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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Recruitment Status : Withdrawn (Strategic decision by Sponsor)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
Sponsor:
Information provided by (Responsible Party):
Inflazome UK Ltd

Brief Summary:
Single center, open-label, intra-individual dose-escalation study in subjects with mild/moderate Parkinson's Disease

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: IZD174 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IZD174
Intra subject dose escalation of IZD174
Drug: IZD174
Small molecule inhibitor of NLRP3




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Secondary Outcome Measures :
  1. 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

  2. Incidence of Treatment-Emergent Adverse Events [ Time Frame: Day 0 to Day 10 ]
    Safety & Tolerability as measured by incidence if Treatment-Emergent Adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Sponsors and Collaborators
Inflazome UK Ltd
Investigators
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Principal Investigator: Teus van Laar, MD, PhD UMCG Groningen
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Responsible Party: Inflazome UK Ltd
ClinicalTrials.gov Identifier: NCT04338997    
Other Study ID Numbers: IZD174-003
First Posted: April 8, 2020    Key Record Dates
Last Update Posted: December 4, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases