PK Study in Patients With Parkinson's Disease With IZD174

December 2, 2020 updated by: Inflazome UK Ltd

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: IZD174
Intra subject dose escalation of IZD174
Small molecule inhibitor of NLRP3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Pre-dose to 36 hours post dose
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
Pre-dose to 36 hours post dose
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
Pre-dose to 36 hours post dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Pre-dose to 36 hours post dose
Incidence of Treatment-Emergent Adverse Events
Time Frame: Day 0 to Day 10
Safety & Tolerability as measured by incidence if Treatment-Emergent Adverse events
Day 0 to Day 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Teus van Laar, MD, PhD, UMCG Groningen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

October 1, 2020

Primary Completion (ANTICIPATED)

November 1, 2020

Study Completion (ANTICIPATED)

December 1, 2020

Study Registration Dates

First Submitted

April 3, 2020

First Submitted That Met QC Criteria

April 7, 2020

First Posted (ACTUAL)

April 8, 2020

Study Record Updates

Last Update Posted (ACTUAL)

December 4, 2020

Last Update Submitted That Met QC Criteria

December 2, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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