Phase 1
Completed N=23
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
Health Volunteers, Huntington Disease
Source: ClinicalTrials.gov NCT03019289 ↗
Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcomePrimary: Sigma-1 Receptor Occupancy — 91.21; 87.19; 86.67; 77.96 percentage of receptor occupancy
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sigma-1 Receptor Occupancy |
91.21; 87.19; 86.67; 77.96; 41.77; 17.55 | — |
| SECONDARY Maximum Plasma Concentration of Pridopidine |
552; 307; 147; 25.9; 2.90; 1.33 | — |
| SECONDARY Time to Reach Maximum (Peak) Concentration (Tmax) |
1.97; 1.98; 1.00; 1.00; 1.98; 1.97 | — |
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
Data sourced from ClinicalTrials.gov (NCT03019289). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.