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Parkinson DiseasePhase 1NCT03903549

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

A Phase 1 study testing [18F]P17-059 in people with Parkinson Disease, run by Five Eleven Pharma, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Parkinson Disease
What is being tested?
[18F]P17-059
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
1 siteUnited States
Study dates
15 Jul 2022to 19 Dec 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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.
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  • 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.
  • 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.
  • Absence of an established clinical movement disorder diagnosis other than Parkinson's disease.
  • 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);
  • Montreal Cognitive Assessment (MoCA) score ≥ 22;
  • Can tolerate imaging visit procedures
  • Willing to give written informed consent and to comply with the study restrictions.
  • 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.
  • In the opinion of the investigator based on medical history and physical examination, can safely tolerate tracer administration and the scanning procedures.

Who cannot join

  • 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.
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  • 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;
  • 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;
  • Have a recent history (within the past year) of alcohol or substance abuse or dependence;
  • Are females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable contraception. Females must not be pregnant (negative serum beta-hCG at the time of screening and negative urine beta-hCG on the day of imaging), must not be breastfeeding at screening, must avoid becoming pregnant and use adequate contraceptive methods for 14 days prior to and 24 hours after administration of 18F-D6-FPDTBZ for injection;
  • Have had prior intracranial surgery; and
  • Are receiving any investigational medications, or have participated in a trial with investigational medications within the last 30 days.
  • Contraindications of MRI. Incidental findings on MRI scans that are pathognomonic for an active disease or pathological process which requires medical intervention will be exclusionary.
  • History of, or suffers from, claustrophobia or feels that he or she will be unable to lie still on their back in the MRI or PET scanner.
  • Urinary toxicology positive for nonprescribed substances
  • Previous allergic reaction to the radiotracer ([18F]D6-FP-DTBZ) or substances of similar chemical structure or excipients.
  • Diagnosis of secondary parkinsonism caused by a brain tumor, cranial trauma, or metabolic diseases (diabetes mellitus, hepatic insufficiency, alcoholism)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Johns Hopkins Medical Institutions

    Baltimore, Maryland, 21287

Other trials in United States

About this study

Official 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)

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.

Being tested
[18F]P17-059
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [18F]P17-059Drug

    Also called [18F]D6FP, [18F]D6FPDTBZ

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

Study groups in NCT03903549
Study groupRoleWhat they receive
Brain uptake and kinetics in Parkinson patientsExperimentalNot described
Receives: Drug: [18F]P17-059
Brain uptake and kinetics in healthy volunteersExperimentalNot described
Receives: Drug: [18F]P17-059
Dosimetry in healthy volunteersExperimentalNot described
Receives: Drug: [18F]P17-059

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 0 - 90 minutes post injection

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

    Dosimetry

    Measured: 0 - 240 minutes post injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2019
  2. Study start15 Jul 2022
  3. Primary completion19 Dec 2022
  4. Study completion19 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03903549
Sponsor's protocol ID
JH-181698
Status last verified
Jan 2023
First submitted
3 Apr 2019
Last updated
11 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [18F]P17-059 in people with Parkinson Disease, run by Five Eleven Pharma, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Regional brain uptake of [18F]P17-057 in Parkinson patients compared healthy volunteers (time frame: 0 - 90 minutes post injection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03903549.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2023.

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