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

NCT03903549 | Completed Phase 1 FDA Drug

• 1 other identifier: JH-181698
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (2)

• Regional brain uptake of [18F]P17-057 in Parkinson patients compared healthy volunteers

  Quantitative estimates of \[18F\]P17-059 uptake in brain - SUV and non-displaceable Binding Potential

  0 - 90 minutes post injection

• Cumulative organ [18F]P17-059 activity for estimates of radiation absorbed dose and effective dose

  Dosimetry

  0 - 240 minutes post injection

Study Arms (3)

Brain uptake and kinetics in Parkinson patients

EXPERIMENTAL

Drug: [18F]P17-059

Brain uptake and kinetics in healthy volunteers

EXPERIMENTAL

Drug: [18F]P17-059

Dosimetry in healthy volunteers

EXPERIMENTAL

Drug: [18F]P17-059

Interventions

[18F]P17-059 DRUG

Injection of \< 10 mCi \[18F\]P17-059 followed by PET/CT scanning

Also known as: [18F]D6FP, [18F]D6FPDTBZ

Brain uptake and kinetics in Parkinson patients; Brain uptake and kinetics in healthy volunteers; Dosimetry in healthy volunteers

Eligibility Criteria

• Age: 45 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy non-smoking males and females, as determined by medical history, physical examination, vital signs, clinical laboratory tests, and an electrocardiogram.
• Male subjects and their child bearing potential partners must be willing to use a reliable method of birth control for the duration of the study.
• Female subjects who are of childbearing potential must agree to use an adequate method of contraception for the duration of the study.
• Between 45-85 years old, inclusive.
• BMI between 18-32 kg/m2 inclusive.
• Have clinical laboratory test results within the reference ranges for the population or results within acceptable deviations that are not considered by the investigator to be clinically significant.
• All subjects and their partners of childbearing potential must commit to use two methods of contraception, one of which must be a barrier method, from the time of screening and throughout the study and until follow-up.
• Less than 195 cm (6 feet and 5 inches) tall in order to accommodate the whole body scanning.
• Have sufficient venous access.
• Willing to give written informed consent and to comply with the study restrictions.
• Signed and dated written informed consent.
• Male or Female.
• Age 45-90.
• Diagnosis of clinically established idiopathic PD consistent with the Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's disease (PD) (Postuma, et al., 2014).
• BMI between 18-32 kg/m2 inclusive.

You may not qualify if:

• Are currently enrolled in or discontinued within the last 30 days from a clinical trial involving an investigational drug or device (other than the study drug) or are currently enrolled in any other type of medical research.
• Are currently experiencing neuropsychiatric illness or severe systemic disease based on history and physical exam.
• Have participated in other research protocols in the last year such that radiation exposure would exceed the annual limits.
• Pregnant or nursing women.
• History of head trauma with prolonged loss of consciousness (\>10 minutes) or any neurological condition including stroke or seizure (excluding childhood febrile seizure).
• History or presence of any clinically relevant hematological, hepatic, respiratory, cardiovascular, renal, metabolic, endocrine, or CNS disease or other medical conditions that are not well controlled, may put the subject at risk, could interfere with the objectives of the study, or make the subject unsuitable for participation in the study for any other reason in the opinion of the principal investigator.
• Suffer from claustrophobia and would be unable to undergo MRI and PET scanning.
• Any confirmed significant allergic reactions against any drug, or multiple allergies.
• Currently uses prescription medications, over-the-counter drugs or herbal remedies such as St. Johns Wort) which cannot be discontinued 14 days (or \< 5 half-lives, whichever is longer), prior to the PET scan and throughout the study. Exceptions include daily multiple vitamins.
• Have a known CNS structural lesion such as stroke or tumor that likely accounts for their symptoms;
• Have current clinically significant cardiovascular disease or clinically important abnormalities on screening ECG (including but not limited to QTc \> 450 msec);
• Are currently taking medications that are known to cause QT-prolongation;
• Are currently taking medications with narrow therapeutic windows (e.g. warfarin or other anticoagulant therapies);
• Are currently taking tetrabenazine (TBZ), valbenazine (Ingrezza), amphetamine type drugs;
• Has taken tetrabenazine (TBZ) in the preceding 3 months;

Sponsors & Collaborators

• Five Eleven Pharma, Inc.: lead

Study Sites (1)

Johns Hopkins Medical Institutions

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Martin Pomper, MD PhD

  Johns Hopkins Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2019
• First Posted: April 4, 2019
• Study Start: July 15, 2022
• Primary Completion: December 19, 2022
• Study Completion: December 19, 2022
• Last Updated: January 11, 2023

Record last verified: 2023-01

Locations

US (1)