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

• Status: Completed
• Trial end date: 2018-02-09
• Target enrollment: 0
• Participant gender: Male

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Prilenia; Teva Branded Pharmaceutical Products, R&D Inc.

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