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

• Register: ClinicalTrials.gov
• Last refreshed on: 23 January 2023
• Main ID: NCT03903549
• Date of registration: 03/04/2019
• Prospective Registration: Yes
• Primary sponsor: Five Eleven Pharma, Inc.
• Public title: Initial Investigation of [18F]P17-059 in Parkinson's Disease Patients and Healthy Volunteers
• Scientific title: A Positron Emission Tomography (PET) Study to Investigate [18F]D6-FP-DTBZ ([18F]P17-059) for Potential Use as a Radioligand for Vesicular Monoamine Transporter (VMAT2)
• Date of first enrolment: July 15, 2022
• Target sample size: 4
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03903549
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Martin Pomper, MD PhD
• Affiliation: Johns Hopkins Medical School

Key inclusion & exclusion criteria

- Inclusion criteria (Healthy Volunteers)

1. Healthy non-smoking males and females, as determined by medical history, physical
examination, vital signs, clinical laboratory tests, and an electrocardiogram.

1.1 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.

1.2 Female subjects who are of childbearing potential must agree to use an
adequate method of contraception for the duration of the study.

2. Between 45-85 years old, inclusive.

3. BMI between 18-32 kg/m2 inclusive.

4. 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.

5. 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.

6. Less than 195 cm (6 feet and 5 inches) tall in order to accommodate the whole
body scanning.

7. Have sufficient venous access.

8. Willing to give written informed consent and to comply with the study
restrictions.

- Inclusion criteria (PD patients)

1. Signed and dated written informed consent.

2. Male or Female.

3. Age 45-90.

4. Diagnosis of clinically established idiopathic PD consistent with the Movement
Disorder Society Clinical Diagnostic Criteria for Parkinson's disease (PD)
(Postuma, et al., 2014).

5. BMI between 18-32 kg/m2 inclusive.

6. 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.

7. 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.

8. Less than 195 cm (6 feet and 5 inches) tall in order to accommodate the whole
body scanning.

9. Have sufficient venous access.

10. Absence of an established clinical movement disorder diagnosis other than
Parkinson's disease.

11. Symptoms mild in intensity, this includes Hoehn & Yahr = 2 (Exceptions are
allowed for subjects who meet criteria for Hoehn & Yahr stage 2/5 due to early
onset of postural instability and/or gait impairment out of proportion to his/her
other Parkinson signs and symptoms);

12. Montreal Cognitive Assessment (MoCA) score = 22;

13. Can tolerate imaging visit procedures

14. Willing to give written informed consent and to comply with the study
restrictions.

15. Female patients must have had her last natural menstruation at least =24 months
prior to the Screening Visit or have been surgically sterilized prior to the
Screening Visit. Male patients must use two methods of contraception in
combination if his female partner is of childbearing potential; OR have been
surgically sterilized prior to the Screening Visit.

16. In the opinion of the investigator based on medical history and physical
examination, can safely tolerate tracer administration and the scanning
procedures.

- exclusion criteria (Healthy volunteers)

1. 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.

2. Are currently experiencing neuropsychiatric illness or severe systemic disease
based on history and physical exam.

3. Have participated in other research protocols in the last year such that
radiation exposure would exceed the annual limits.

4. Pregnant or nursing women.

5. History of head trauma with prolonged loss of consciousness (>10 minutes) or any
neurological condition including stroke or seizure (excluding childhood febrile
seizure).

6. 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.

7. Suffer from claustrophobia and would be unable to undergo MRI and PET scanning.

8. Any confirmed significant allergic reactions against any drug, or multiple
allergies.

9. 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.

- exclusion criteria (PD patients)

1. Have a known CNS structural lesion such as stroke or tumor that likely accounts
for their symptoms;

2. Have current clinically significant cardiovascular disease or clinically
important abnormalities on screening ECG (including but not limited to QTc > 450
msec);

3. Are currently taking medications that are known to cause QT-prolongation;

4. Are currently taking medications with narrow therapeutic windows (e.g. warfarin
or other anticoagulant therapies);

5. Are currently taking tetrabenazine (TBZ), valbenazine (Ingrezza), amphetamine
type drugs;

6. Has taken tetrabenazine (TBZ) in the preceding 3 months;

7. Have a current clinically significant endocrine or metabolic disease, pulmonary,
renal or hepatic impairment, or cancer (excluding localized basal cell carcinoma
and in situ prostate cancer) that would interfere with completion of the study;

8. Have a recent history (within the past year) of alcohol or substance abuse or
dependence;

9. Are females


Age minimum: 45 Years
Age maximum: 90 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson Disease

Intervention(s)

Drug: [18F]P17-059

Primary Outcome(s)

Regional brain uptake of [18F]P17-057 in Parkinson patients compared healthy volunteers [Time Frame: 0 - 90 minutes post injection]

Cumulative organ [18F]P17-059 activity for estimates of radiation absorbed dose and effective dose [Time Frame: 0 - 240 minutes post injection]

Secondary ID(s)

JH-181698

Source(s) of Monetary Support

Please refer to primary and secondary sponsors