NCT04338997

PK Study in Patients With Parkinson's Disease With IZD174

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

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Inflazome UK Ltd · Industry
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DRUG	IZD174	Small molecule inhibitor of NLRP3

Timeline

• Start date: 2020-10-01
• Primary completion: 2020-11-01
• Completion: 2020-12-01
• First posted: 2020-04-08
• Last updated: 2020-12-04