Initial Investigation of [18F]P17-059 in Parkinson's Disease Patients and Healthy Volunteers

Phase 1

Completed

• Conditions: Parkinson Disease
• Interventions: Drug: [18F]P17-059

• Registration Number: NCT03903549
• Lead Sponsor: Five Eleven Pharma, Inc.

Brief Summary

This study investigates the initial safety profile of \[18F\]P17-059 in healthy volunteers including dosimetry determination, and compares regional brain uptake and kinetics of \[18F\]P17-059 in Parkinson's disease patients with regional brain uptake and kinetics of \[18F\]P17-059 in healthy volunteers.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-03
• Study First Submitted QC: 2019-04-03
• Study First Posted: 2019-04-04
• Study Start: 2022-07-15
• Primary Completion: 2022-12-19
• Study Completion: 2022-12-19
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-10
• Last Update Posted: 2023-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dosimetry in healthy volunteers	[18F]P17-059	-
Brain uptake and kinetics in healthy volunteers	[18F]P17-059	-
Brain uptake and kinetics in Parkinson patients	[18F]P17-059	-

Primary Outcome Measures

Name	Time	Method
Regional brain uptake of [18F]P17-057 in Parkinson patients compared healthy volunteers	0 - 90 minutes post injection	Quantitative estimates of \[18F\]P17-059 uptake in brain - SUV and non-displaceable Binding Potential
Cumulative organ [18F]P17-059 activity for estimates of radiation absorbed dose and effective dose	0 - 240 minutes post injection	Dosimetry

Trial Locations

Locations (1)

Johns Hopkins Medical Institutions; 🇺🇸 Baltimore, Maryland, United States