Clinical trial NCT03019289: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Health Volunteers, Huntington Disease
Lead sponsor: Prilenia
Sponsor class: INDUSTRY
First posted: 2017-01-12
Enrollment: 23
Sex: MALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: Sigma-1 Receptor Occupancy
timeFrame: 2 hours after oral administration of pridopidine
Secondary outcomes:
measure: Maximum Plasma Concentration of Pridopidine
timeFrame: 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.
measure: Time to Reach Maximum (Peak) Concentration (Tmax)
timeFrame: 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.
Other outcomes:
measure: Dopamine-2 Receptor Occupancy
timeFrame: 2 h after pridopidine dosing
Locations:
city: Leipzig
country: Germany
facility: Teva Investigational Site 32648
Study officials:
affiliation: Teva Pharmaceuticals USA
name: Teva Medical Expert, MD
role: STUDY_DIRECTOR
References:
citation: 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.