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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Prilenia · Industry
• Sex: Male
• Age: 25 Years
• Healthy volunteers: Accepted

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

Conditions

• Health Volunteers, Huntington Disease

Interventions

Type	Name	Description
DRUG	pridopidine (90 mg)	single dose will be administered in Cohort 1. Other optional cohorts 2 and 3 may include single dose 0.5 mg, 1 mg, 2.5 mg, 5 mg, 10 mg, 22.5 mg, 45 mg, or 90 mg. The dose will be selected based on the results obtained from Cohorts 1 and 2.

Timeline

• Start date: 2017-04-19
• Primary completion: 2018-02-09
• Completion: 2018-02-09
• First posted: 2017-01-12
• Last updated: 2021-11-19
• Results posted: 2021-11-16

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated drug study