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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-001757-41 | EudraCT Number |
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The purpose of this study is to demonstrate engagement of pridopidine with S1R and D2R (optional) in the living human brain. No formal statistical analysis will be conducted
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pridopidine | Experimental | Pridopidine (TV-7820) capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pridopidine (90 mg) | Drug | single dose will be administered in Cohort 1. Other optional cohorts 2 and 3 may include single dose 0.5 mg, 1 mg, 2.5 mg, 5 mg, 10 mg, 22.5 mg, 45 mg, or 90 mg. The dose will be selected based on the results obtained from Cohorts 1 and 2. |
| Measure | Description | Time Frame |
|---|---|---|
| Sigma-1 Receptor Occupancy | Receptor occupancy of pridopidine to Sigma-1 receptors (S1R) in the brain was assessed from Positron Emission Tomography (PET) imaging with (S)-(-)-[18F]fluspidine | 2 hours after oral administration of pridopidine |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration of Pridopidine | Maximum plasma concentration of pridopidine based on noncompartmental analysis | 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. |
| Time to Reach Maximum (Peak) Concentration (Tmax) |
| Measure | Description | Time Frame |
|---|---|---|
| Dopamine-2 Receptor Occupancy | RO of D2 (Dopamine-2) at 2 hours after oral administration of pridopidine (90 mg dose level) was investigated in 4 healthy volunteers using [18F]fallypride | 2 h after pridopidine dosing |
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
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.
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| Name | Affiliation | Role |
|---|---|---|
| Teva Medical Expert, MD | Teva Pharmaceuticals USA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Teva Investigational Site 32648 | Leipzig | 04103 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32995944 | Background | Grachev ID, Meyer PM, Becker GA, Bronzel M, Marsteller D, Pastino G, Voges O, Rabinovich L, Knebel H, Zientek F, Rullmann M, Sattler B, Patt M, Gerhards T, Strauss M, Kluge A, Brust P, Savola JM, Gordon MF, Geva M, Hesse S, Barthel H, Hayden MR, Sabri O. Sigma-1 and dopamine D2/D3 receptor occupancy of pridopidine in healthy volunteers and patients with Huntington disease: a [18F] fluspidine and [18F] fallypride PET study. Eur J Nucl Med Mol Imaging. 2021 Apr;48(4):1103-1115. doi: 10.1007/s00259-020-05030-3. Epub 2020 Sep 29. |
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The screening period had a duration of up to 8 weeks. A total of 49 healthy subjects and 3 HD patients were screened; of these, 20 healthy subjects and 3 HD patients met the eligibility criteria and were enrolled in the study.
Healthy volunteers (HV) and patients with Huntington Disease (HD) were enrolled. The first participant was enrolled on 22 March 2017; the last subject completed the study on 09 February 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | A: Cohort 1: P90 + (S)-(-)-FPD; HV | Healthy volunteers (HV) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study |
| FG001 | A: Cohort 2: P45 + (S)-(-)-FPD; HV |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 2, 2016 | Oct 18, 2021 |
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Multiple PK samples over 24 hours will be calculated for pridopidine and its metabolite TV-45065 in plasma using non-compartmental methods, when possible. |
| 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. |
Healthy volunteers (HV) receiving a single dose of 45 mg pridopidine (P45) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study |
| FG002 | A: Cohort 2: P22.5 + (S)-(-)-FPD; HV | Healthy volunteers (HV) receiving a single dose of 22.5 mg pridopidine (P22.5) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study |
| FG003 | A: Cohort 3: P5 + (S)-(-)-FPD; HV | Healthy volunteers (HV) receiving a single dose of 5 mg pridopidine (P5) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study |
| FG004 | A: Cohort 7: P1 + (S)-(-)-FPD; HV | Healthy volunteers (HV) receiving a single dose of 1 mg pridopidine (P1) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study |
| FG005 | A: Cohort 7: P0.5 + (S)-(-)-FPD; HV | Healthy volunteers (HV) receiving a single dose of 0.5 mg pridopidine (P0.5) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study |
| FG006 | A: Cohort 6; P90 + (S)-(-)-FPD; HD | Patients with Huntington's Disease (HD) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study |
| FG007 | B: Cohort 4: P90 + Fallypride; HV | Healthy volunteers (HV) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer [18F]fallypride for neuroimaging in Part B of the study |
| FG008 | Cohort 0: (S)-(-)-FPD, HV | Healthy volunteers (HV) receiving a single dose of radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging |
| COMPLETED |
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| NOT COMPLETED |
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All subjects/patients enrolled
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| ID | Title | Description |
|---|---|---|
| BG000 | A: Cohort 1: P90 + (S)-(-)-FPD; HV | Healthy volunteers (HV) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study |
| BG001 | A: Cohort 2: P45 + (S)-(-)-FPD; HV | Healthy volunteers (HV) receiving a single dose of 45 mg pridopidine (P45) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study |
| BG002 | A: Cohort 2: P22.5 + (S)-(-)-FPD; HV | Healthy volunteers (HV) receiving a single dose of 22.5 mg pridopidine (P22.5) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study |
| BG003 | A: Cohort 3: P5 + (S)-(-)-FPD; HV | Healthy volunteers (HV) receiving a single dose of 5 mg pridopidine (P5) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study |
| BG004 | A: Cohort 7: P1 + (S)-(-)-FPD; HV | Healthy volunteers (HV) receiving a single dose of 1 mg pridopidine (P1) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study |
| BG005 | A: Cohort 7: P0.5 + (S)-(-)-FPD; HV | Healthy volunteers (HV) receiving a single dose of 0.5 mg pridopidine (P0.5) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study |
| BG006 | A: Cohort 6; P90 + (S)-(-)-FPD; HD | Patients with Huntington's Disease (HD) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study |
| BG007 | B: Cohort 4: P90 + Fallypride; HV | Healthy volunteers (HV) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer [18F]fallypride for neuroimaging in Part B of the study |
| BG008 | Cohort 0: (S)-(-)-FPD, HV | Healthy volunteers (HV) receiving a single dose of radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging |
| BG009 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||
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| Primary | Sigma-1 Receptor Occupancy | Receptor occupancy of pridopidine to Sigma-1 receptors (S1R) in the brain was assessed from Positron Emission Tomography (PET) imaging with (S)-(-)-[18F]fluspidine | Patients enrolled and receiving pridopidine. Patients from Cohort B (receiving fallypride only) and Cohort 0 (no pridopidine treatment) were not included in the analysis | Posted | Mean | Full Range | percentage of receptor occupancy | 2 hours after oral administration of pridopidine |
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| Secondary | Maximum Plasma Concentration of Pridopidine | Maximum plasma concentration of pridopidine based on noncompartmental analysis | Patients enrolled who received pridopidine and had sufficient data to calculate at least 1 evaluable pharmacokinetic parameter for pridopidine. | Posted | Geometric Mean | Full Range | ng/mL | 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 | Time to Reach Maximum (Peak) Concentration (Tmax) | Multiple PK samples over 24 hours will be calculated for pridopidine and its metabolite TV-45065 in plasma using non-compartmental methods, when possible. | Patients enrolled who received pridopidine and had sufficient data to calculate at least 1 evaluable pharmacokinetic parameter for pridopidine | Posted | Median | Full Range | hours | 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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| Other Pre-specified | Dopamine-2 Receptor Occupancy | RO of D2 (Dopamine-2) at 2 hours after oral administration of pridopidine (90 mg dose level) was investigated in 4 healthy volunteers using [18F]fallypride | Patients enrolled and treated | Posted | Mean | Standard Deviation | percent volume/volume | 2 h after pridopidine dosing |
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From signing of the informed consent through to 7 days after the last administration of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | A: Cohort 1: P90 + (S)-(-)-FPD; HV | Healthy volunteers (HV) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study | 0 | 5 | 0 | 5 | 2 | 5 |
| EG001 | A: Cohort 2: P45 + (S)-(-)-FPD; HV | Healthy volunteers (HV) receiving a single dose of 45 mg pridopidine (P45) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study | 0 | 1 | 0 | 1 | 1 | 1 |
| EG002 | A: Cohort 2: P22.5 + (S)-(-)-FPD; HV | Healthy volunteers (HV) receiving a single dose of 22.5 mg pridopidine (P22.5) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study | 0 | 3 | 0 | 3 | 1 | 3 |
| EG003 | A: Cohort 3: P5 + (S)-(-)-FPD; HV | Healthy volunteers (HV) receiving a single dose of 5 mg pridopidine (P5) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study | 0 | 2 | 0 | 2 | 0 | 2 |
| EG004 | A: Cohort 7: P1 + (S)-(-)-FPD; HV | Healthy volunteers (HV) receiving a single dose of 1 mg pridopidine (P1) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study | 0 | 1 | 0 | 1 | 0 | 1 |
| EG005 | A: Cohort 7: P0.5 + (S)-(-)-FPD; HV | Healthy volunteers (HV) receiving a single dose of 0.5 mg pridopidine (P0.5) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study | 0 | 1 | 0 | 1 | 0 | 1 |
| EG006 | A: Cohort 6; P90 + (S)-(-)-FPD; HD | Patients with Huntington's Disease (HD) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study | 0 | 3 | 0 | 3 | 1 | 3 |
| EG007 | B: Cohort 4: P90 + Fallypride; HV | Healthy volunteers (HV) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer [18F]fallypride for neuroimaging in Part B of the study | 0 | 4 | 0 | 4 | 1 | 4 |
| EG008 | Cohort 0: (S)-(-)-FPD, HV | Healthy volunteers (HV) receiving a single dose of radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging | 0 | 3 | 0 | 3 | 3 | 3 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Catheter site hematoma | General disorders | MedDRA (19.1) | Non-systematic Assessment |
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| Catheter site pain | General disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Catheter site paraesthisia | General disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Vessel puncture site haematoma | General disorders | MedDRA (19.1) | Non-systematic Assessment |
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| Conjunctivitis | Infections and infestations | MedDRA (19.1) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (19.1) | Non-systematic Assessment |
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| Skin abrasion | Injury, poisoning and procedural complications | MedDRA (19.1) | Non-systematic Assessment |
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| Sports injury | Injury, poisoning and procedural complications | MedDRA (19.1) | Non-systematic Assessment |
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| Haemoglobin decreased | Investigations | MedDRA (19.1) | Non-systematic Assessment |
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| Haematocrit decreased | Investigations | MedDRA (19.1) | Non-systematic Assessment |
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| Red blood cell count decreased | Investigations | MedDRA (19.1) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (19.1) | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Non-systematic Assessment |
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Data and results are owned by the sponsor. Results can be used by the institution for internal noncommercial research, education and patient care, and as required under applicable laws and regulations. Other uses require prior written consent of the sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prilenia | Prilenia | +972 775558 | 482 | info@prilenia.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 1, 2018 | Oct 18, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D006816 | Huntington Disease |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D003704 | Dementia |
| D002819 | Chorea |
| D020820 | Dyskinesias |
| D009069 | Movement Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C483720 | pridopidine |
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| Male |
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| Black/African American |
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| OG003 | A: Cohort 3: P5 + (S)-(-)-FPD; HV | Healthy volunteers (HV) receiving a single dose of 5 mg pridopidine (P5) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study |
| OG004 | A: Cohort 7: P1 + (S)-(-)-FPD; HV | Healthy volunteers (HV) receiving a single dose of 1 mg pridopidine (P1) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study |
| OG005 | A: Cohort 7: P0.5 + (S)-(-)-FPD; HV | Healthy volunteers (HV) receiving a single dose of 0.5 mg pridopidine (P0.5) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study |
| OG006 | A: Cohort 6; P90 + (S)-(-)-FPD; HD | Patients with Huntington's Disease (HD) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study |
| OG007 | B: Cohort 4: P90 + FPD; HV | Healthy volunteers (HV) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer [18F]fallypride for neuroimaging in Part B of the study |
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| OG003 | A: Cohort 3: P5 + (S)-(-)-FPD; HV | Healthy volunteers (HV) receiving a single dose of 5 mg pridopidine (P5) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study |
| OG004 | A: Cohort 7: P1 + (S)-(-)-FPD; HV | Healthy volunteers (HV) receiving a single dose of 1 mg pridopidine (P1) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study |
| OG005 | A: Cohort 7: P0.5 + (S)-(-)-FPD; HV | Healthy volunteers (HV) receiving a single dose of 0.5 mg pridopidine (P0.5) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study |
| OG006 | A: Cohort 6; P90 + (S)-(-)-FPD; HD | Patients with Huntington's Disease (HD) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study |
| OG007 | B: Cohort 4: P90 + Fallypride; HV | Healthy volunteers (HV) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer [18F]fallypride for neuroimaging in Part B of the study |
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