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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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29 November 2021 |
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Main ID: |
NCT03019289 |
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Date of registration:
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03/01/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study to Evaluate Sigma-1 and Dopamine-2 Receptor Occupancy by Pridopidine in the Human Brain of Healthy Volunteers and in Patients With Huntington's Disease
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Scientific title:
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A Phase I, Open-Label, Single-Dose, Adaptive (S)-(-)-[18F]Fluspidine and [18F]Fallypride Positron Emission Tomography Study to Evaluate Sigma-1 and Dopamine-2 Receptor Occupancy by Pridopidine in the Human Brain of Healthy Volunteers and in Patients With Huntington's Disease |
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Date of first enrolment:
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April 19, 2017 |
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Target sample size:
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23 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03019289 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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Germany
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Contacts
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Name:
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Teva Medical Expert, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Teva Pharmaceuticals USA |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- In general, good physical health as determined by medical history and psychiatric
history, suicidality assessment & physical examination
- Men who are potentially fertile (not surgically [eg, vasectomy] or congenitally
sterile
- Patients with Huntington's disease (HD): diagnosis of HD and with an onset of HD after
18 years of age
- Additional criteria apply, please contact the investigator for more information
Exclusion Criteria:
- The subject has been previously exposed to ionizing radiation or radioactive
substances as a result of clinical research or medical treatment in the past 10 years.
- The subject has a counterindication to having an MRI
- History of alcohol, narcotic, or any other substance dependence in the past 2 years
- Additional Exclusion criteria to patients with Huntington's disease:
- The patient has a severe motor impairment that might cause artifacts.
- Patients with a known history of Long QT Syndrome or a first degree relative with this
condition.
- Treatment with any investigational product within 6 weeks of screening or patients
planning to participate in another clinical study assessing any investigational
product during the study.
- Additional criteria apply, please contact the investigator for more information
Age minimum:
25 Years
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Health Volunteers, Huntington Disease
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Intervention(s)
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Drug: pridopidine (90 mg)
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Primary Outcome(s)
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Sigma-1 Receptor Occupancy
[Time Frame: 2 hours after oral administration of pridopidine]
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Secondary Outcome(s)
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Maximum Plasma Concentration of Pridopidine
[Time Frame: PK sampling 1 h before pridopidine dosing, and 5, 15, 30, 45, 60 min, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 h after dosing.]
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Time to Reach Maximum (Peak) Concentration (Tmax)
[Time Frame: PK sampling 1 h before pridopidine dosing, and 5, 15, 30, 45, 60 min, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 h after dosing.]
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Secondary ID(s)
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TV7820-IMG-10082
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2016-001757-41
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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