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Trial record 4 of 6 for:    Pridopidine | Huntington Disease

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

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ClinicalTrials.gov Identifier: NCT03019289
Recruitment Status : Completed
First Posted : January 12, 2017
Last Update Posted : September 26, 2018
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )

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

Condition or disease Intervention/treatment Phase
Health Volunteers, Huntington Disease Drug: pridopidine (90 mg) Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official 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
Actual Study Start Date : April 19, 2017
Actual Primary Completion Date : February 9, 2018
Actual Study Completion Date : February 9, 2018


Arm Intervention/treatment
Experimental: pridopidine
Pridopidine (TV-7820) capsules
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 67.5 mg. The dose will be selected based on the results obtained from Cohorts 1 and 2.




Primary Outcome Measures :
  1. Pharmacodynamic Assessment- Positron Emission Tomography (PET) acquisition [ Time Frame: Day 1 ]
    Pharmacodynamic Assessment- Positron Emission Tomography (PET) acquisition


Secondary Outcome Measures :
  1. Pharmacokinetic Assessment- maximum observed concentration (Cmax) [ Time Frame: Over 24 hour period ]
    Multiple PK samples over 24 hours will be calculated for pridopidine and its metabolite TV-45065 in plasma using non-compartmental methods, when possible.

  2. Pharmacokinetic Assessment- time to reach maximum (peak) concentration (tmax) [ Time Frame: Over 24 hour period ]
    Multiple PK samples over 24 hours will be calculated for pridopidine and its metabolite TV-45065 in plasma using non-compartmental methods, when possible.

  3. Pharmacokinetic Assessment- area under the drug concentration by time curve (AUC) [ Time Frame: Over 24 hour period ]
    Multiple PK samples over 24 hours will be calculated for pridopidine and its metabolite TV-45065 in plasma using non-compartmental methods, when possible.

  4. Pharmacokinetic Assessment- terminal elimination half-life (t1/2) [ Time Frame: Over 24 hour period ]
    Multiple PK samples over 24 hours will be calculated for pridopidine and its metabolite TV-45065 in plasma using non-compartmental methods, when possible.

  5. Pharmacokinetic Assessment- apparent volume of distribution of the drug following extravascular administration (Vd/F) [ Time Frame: Over 24 hour period ]
    Multiple PK samples over 24 hours will be calculated for pridopidine and its metabolite TV-45065 in plasma using non-compartmental methods, when possible.

  6. Percentage of Participants with Adverse Events [ Time Frame: 4 weeks ]
    Percentage of Participants with Adverse Events



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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03019289


Locations
Germany
Teva Investigational Site 32648
Leipzig, Germany, 04103
Sponsors and Collaborators
Teva Branded Pharmaceutical Products, R&D Inc.
Investigators
Study Director: Teva Medical Expert, MD Teva Pharmaceuticals USA

Responsible Party: Teva Branded Pharmaceutical Products, R&D Inc.
ClinicalTrials.gov Identifier: NCT03019289     History of Changes
Other Study ID Numbers: TV7820-IMG-10082
2016-001757-41 ( EudraCT Number )
First Posted: January 12, 2017    Key Record Dates
Last Update Posted: September 26, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Dementia
Chorea
Dyskinesias
Dopamine
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents