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

Phase 1

Completed

• Conditions: Health Volunteers, Huntington Disease
• Interventions: Drug: pridopidine (90 mg)

• Registration Number: NCT03019289
• Lead Sponsor: Prilenia

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-03
• Study First Submitted QC: 2017-01-11
• Study First Posted: 2017-01-12
• Study Start: 2017-04-19
• Primary Completion: 2018-02-09
• Study Completion: 2018-02-09
• Results First Submitted: 2021-10-18
• Results First Submitted QC: 2021-10-18
• Status Verified: 2021-11
• Results First Posted: 2021-11-16
• Last Update Submitted: 2021-11-18
• Last Update Posted: 2021-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
pridopidine	pridopidine (90 mg)	Pridopidine (TV-7820) capsules

Primary Outcome Measures

Name	Time	Method
Sigma-1 Receptor Occupancy	2 hours after oral administration of pridopidine	Receptor occupancy of pridopidine to Sigma-1 receptors (S1R) in the brain was assessed from Positron Emission Tomography (PET) imaging with (S)-(-)-\[18F\]fluspidine

Secondary Outcome Measures

Name	Time	Method
Maximum Plasma Concentration of Pridopidine	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.	Maximum plasma concentration of pridopidine based on noncompartmental analysis
Time to Reach Maximum (Peak) Concentration (Tmax)	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.	Multiple PK samples over 24 hours will be calculated for pridopidine and its metabolite TV-45065 in plasma using non-compartmental methods, when possible.

Trial Locations

Locations (1)

Teva Investigational Site 32648; 🇩🇪 Leipzig, Germany