Clinical trial NCT04338997: 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
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Parkinson Disease
Lead sponsor: Inflazome UK Ltd
Sponsor class: INDUSTRY
First posted: 2020-04-08
Enrollment: 0
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Concentration of IZD174 in plasma
timeFrame: Pre-dose to 36 hours post dose
measure: Concentration of IZD174 in cerebrospinal fluid
timeFrame: Pre-dose to 36 hours post dose
measure: Ratio of IZD174 concentration in plasma to CSF
timeFrame: Pre-dose to 36 hours post dose
Secondary outcomes:
measure: Inhibition of Interleukin-1 beta secretion in ex-vivo stimulated whole blood
timeFrame: Pre-dose to 36 hours post dose
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: Day 0 to Day 10
Other outcomes:
Locations:
Study officials:
affiliation: UMCG Groningen
name: Teus van Laar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: