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Completed

NCT Number: 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

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

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Key information

Conditions

Health Volunteers, Huntington Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Chorea Cognition Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dementia Dyskinesias Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Huntington Disease Mental Disorders Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases

Age range

25 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Teva Investigational Site 32648

Leipzig, 04103, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pridopidine (90 mg)

Drug

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.

Primary outcomes

  1. Sigma-1 Receptor Occupancy

    Time frame: 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 outcomes

  1. Maximum Plasma Concentration of Pridopidine

    Time frame: 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

  2. Time to Reach Maximum (Peak) Concentration (Tmax)

    Time frame: 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.

Other outcomes

  1. Dopamine-2 Receptor Occupancy

    Time frame: 2 h after pridopidine dosing

    RO of D2 (Dopamine-2) at 2 hours after oral administration of pridopidine (90 mg dose level) was investigated in 4 healthy volunteers using [18F]fallypride

Sponsors and collaborators

Lead sponsor

Prilenia

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 12, 2017
Registry last updated
Nov 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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