Health Volunteers, Huntington Disease Clinical Trial
Official title:
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
| Verified date | November 2021 |
| Source | Prilenia |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 23 |
| Est. completion date | February 9, 2018 |
| Est. primary completion date | February 9, 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 25 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Teva Investigational Site 32648 | Leipzig |
| Lead Sponsor | Collaborator |
|---|---|
| Prilenia |
Germany,
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 [(18)F] fluspidine and [(18)F] 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | 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 | |
| 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 | 2 hours after oral administration of pridopidine | |
| Secondary | 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. | |
| 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. | 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. |