PK Study in Patients With Parkinson's Disease With IZD174

Parkinson Disease Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04338997
• Other study ID #: IZD174-003
• Status: Withdrawn
• Phase: Phase 1
• Start date: October 2020
• Est. completion date: December 2020

Study information

• Verified date: September 2020
• Source: Inflazome UK Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2020
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Drug:
• IZD174
Small molecule inhibitor of NLRP3

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Inflazome UK Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of IZD174 in plasma	Plasma PK profile following an intra-individual dose escalation of IZD174	Pre-dose to 36 hours post dose
Primary	Concentration of IZD174 in cerebrospinal fluid	CSF PK profile following an intra-individual dose escalation of IZD174	Pre-dose to 36 hours post dose
Primary	Ratio of IZD174 concentration in plasma to CSF	CSF to plasma concentration ratio at each time point	Pre-dose to 36 hours post dose
Secondary	Inhibition of Interleukin-1 beta secretion in ex-vivo stimulated whole blood	Inhibition of IL-1 secretion by ex-vivo stimulated whole blood	Pre-dose to 36 hours post dose
Secondary	Incidence of Treatment-Emergent Adverse Events	Safety & Tolerability as measured by incidence if Treatment-Emergent Adverse events	Day 0 to Day 10