NCT03019289

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 12, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

April 19, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 9, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 9, 2018

Completed
3.8 years until next milestone

Results Posted

Study results publicly available

November 16, 2021

Completed
Last Updated

November 19, 2021

Status Verified

November 1, 2021

Enrollment Period

10 months

First QC Date

January 3, 2017

Results QC Date

October 18, 2021

Last Update Submit

November 18, 2021

Conditions

Health Volunteers, Huntington Disease

Outcome Measures

Primary Outcomes (1)

  • Sigma-1 Receptor Occupancy

    Receptor occupancy of pridopidine to Sigma-1 receptors (S1R) in the brain was assessed from Positron Emission Tomography (PET) imaging with (S)-(-)-\[18F\]fluspidine

    2 hours after oral administration of pridopidine

Secondary Outcomes (2)

  • 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.

  • 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.

Other Outcomes (1)

  • Dopamine-2 Receptor Occupancy

    2 h after pridopidine dosing

Study Arms (1)

pridopidine

EXPERIMENTAL

Pridopidine (TV-7820) capsules

Drug: pridopidine (90 mg)

Interventions

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.

pridopidine

Eligibility Criteria

Age25 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Teva Investigational Site 32648

Leipzig, 04103, Germany

Location

Related Publications (1)

  • Grachev ID, Meyer PM, Becker GA, Bronzel M, Marsteller D, Pastino G, Voges O, Rabinovich L, Knebel H, Zientek F, Rullmann M, Sattler B, Patt M, Gerhards T, Strauss M, Kluge A, Brust P, Savola JM, Gordon MF, Geva M, Hesse S, Barthel H, Hayden MR, Sabri O. Sigma-1 and dopamine D2/D3 receptor occupancy of pridopidine in healthy volunteers and patients with Huntington disease: a [18F] fluspidine and [18F] fallypride PET study. Eur J Nucl Med Mol Imaging. 2021 Apr;48(4):1103-1115. doi: 10.1007/s00259-020-05030-3. Epub 2020 Sep 29.

    PMID: 32995944BACKGROUND

MeSH Terms

Conditions

Huntington Disease

Interventions

pridopidine

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesDementiaChoreaDyskinesiasMovement DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCognition DisordersNeurocognitive DisordersMental Disorders

Results Point of Contact

Title
Prilenia
Organization
Prilenia
info@prilenia.com
+972 775558

Study Officials

  • Teva Medical Expert, MD

    Teva Pharmaceuticals USA

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2017

First Posted

January 12, 2017

Study Start

April 19, 2017

Primary Completion

February 9, 2018

Study Completion

February 9, 2018

Last Updated

November 19, 2021

Results First Posted

November 16, 2021

Record last verified: 2021-11

Locations

DE(1)