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

Prilenia

Status and phase

Completed

Phase 1

Conditions

Health Volunteers, Huntington Disease

Treatments

Drug: pridopidine (90 mg)

Study type

Interventional

Funder types

Industry

Identifiers

NCT03019289

TV7820-IMG-10082

2016-001757-41 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment

23 patients

Sex

Male

Ages

25+ years old

Volunteers

Accepts Healthy Volunteers

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