Health Volunteers, Huntington DiseasePhase 1NCT03019289

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 1 study testing pridopidine (90 mg) in people with Health Volunteers, Huntington Disease, run by Prilenia at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 25 years and older, men onlyHealthy volunteers can take part
Conditions the study is for: Health Volunteers, Huntington Disease
What is being tested?: pridopidine (90 mg)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 23 participants
Where: 1 siteGermany
Study dates: 19 Apr 2017to 9 Feb 2018
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 25 years and older
Men only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Germany1 site

Teva Investigational Site 32648
Leipzig, 04103

Other trials in Germany

About this study

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

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
Being tested: pridopidine (90 mg)
Medical subject headings: Huntington Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT03019289
Study group	Role	What they receive
pridopidine	Experimental	Pridopidine (TV-7820) capsules Receives: Drug: pridopidine (90 mg)

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 2 hours after oral administration of pridopidine

Secondary outcomes (2)

Maximum Plasma Concentration of Pridopidine
Maximum plasma concentration of pridopidine based on noncompartmental analysis
Measured: 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)
Multiple PK samples over 24 hours will be calculated for pridopidine and its metabolite TV-45065 in plasma using non-compartmental methods, when possible.
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Apr 20179 Feb 2018

First posted12 Jan 2017 (estimated)
Study start19 Apr 2017
Primary completion9 Feb 2018
Study completion9 Feb 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Health Volunteers, Huntington DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03019289
Sponsor's protocol ID: TV7820-IMG-10082
Other IDs: 2016-001757-41, 2016
Status last verified: Nov 2021
First submitted: 3 Jan 2017
Last updated: 19 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

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.
PubMed 32995944

Study at a glance

From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03019289
Acronym / sponsor ID: TV7820-IMG-10082
Conditions: Health Volunteers, Huntington Disease
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 23 participants (actual)
Lead sponsor: PrileniaIndustry (pharma, biotech, devices)
Study start: 19 Apr 2017 (actual)
Primary completion: 9 Feb 2018 (actual)
Study completion: 9 Feb 2018 (actual)
First posted: 12 Jan 2017 (estimated)
Results: Posted 16 Nov 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
pridopidine	Experimental	Drug: pridopidine (90 mg)Pridopidine (TV-7820) capsules

Who may qualify

Ages: 25 years and older
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (8 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Drug	pridopidine

Primary outcome

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

2 secondary outcomes

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.
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.

Results and safety

Results posted to the registry on 16 Nov 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
A: Cohort 1: P90 + (S)-(-)-FPD; HV	5	3
A: Cohort 2: P45 + (S)-(-)-FPD; HV	1	1
A: Cohort 2: P22.5 + (S)-(-)-FPD; HV	3	3
A: Cohort 3: P5 + (S)-(-)-FPD; HV	2	2
A: Cohort 7: P1 + (S)-(-)-FPD; HV	1	1
A: Cohort 7: P0.5 + (S)-(-)-FPD; HV	1	1
A: Cohort 6; P90 + (S)-(-)-FPD; HD	3	3
B: Cohort 4: P90 + Fallypride; HV	4	4
Cohort 0: (S)-(-)-FPD, HV	3	2

Primary outcome: Sigma-1 Receptor Occupancy

Time frame: 2 hours after oral administration of pridopidine. Mean (Full Range). Unit: percentage of receptor occupancy

Measure	A: Cohort 1: P90 + (S)-(-)-FPD; HV n = 3	A: Cohort 2: P45 + (S)-(-)-FPD; HV n = 1	A: Cohort 2: P22.5 + (S)-(-)-FPD; HV n = 3	A: Cohort 3: P5 + (S)-(-)-FPD; HV n = 2	A: Cohort 7: P1 + (S)-(-)-FPD; HV n = 1	A: Cohort 7: P0.5 + (S)-(-)-FPD; HV n = 1	A: Cohort 6; P90 + (S)-(-)-FPD; HD n = 3
Value	91.21 (88.82 to 95.67)	87.19 (87.19 to 87.19)	86.67 (84.06 to 89.24)	77.96 (76.75 to 79.16)	41.77 (41.77 to 41.77)	17.55 (17.55 to 17.55)	87.37 (80.36 to 93.23)

Population analysed: Patients enrolled and receiving pridopidine. Patients from Cohort B (receiving fallypride only) and Cohort 0 (no pridopidine treatment) were not included in the analysis

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From signing of the informed consent through to 7 days after the last administration of study drug.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
A: Cohort 1: P90 + (S)-(-)-FPD; HV	0 of 5 (0%)	2 of 5 (40%)	0 of 5
A: Cohort 2: P45 + (S)-(-)-FPD; HV	0 of 1 (0%)	1 of 1 (100%)	0 of 1
A: Cohort 2: P22.5 + (S)-(-)-FPD; HV	0 of 3 (0%)	1 of 3 (33.3%)	0 of 3
A: Cohort 3: P5 + (S)-(-)-FPD; HV	0 of 2 (0%)	0 of 2 (0%)	0 of 2
A: Cohort 7: P1 + (S)-(-)-FPD; HV	0 of 1 (0%)	0 of 1 (0%)	0 of 1
A: Cohort 7: P0.5 + (S)-(-)-FPD; HV	0 of 1 (0%)	0 of 1 (0%)	0 of 1
A: Cohort 6; P90 + (S)-(-)-FPD; HD	0 of 3 (0%)	1 of 3 (33.3%)	0 of 3
B: Cohort 4: P90 + Fallypride; HV	0 of 4 (0%)	1 of 4 (25%)	0 of 4
Cohort 0: (S)-(-)-FPD, HV	0 of 3 (0%)	3 of 3 (100%)	0 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 32995944Grachev 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Teva Medical Expert, MD study director

Teva Pharmaceuticals USA

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing pridopidine (90 mg) in people with Health Volunteers, Huntington Disease, run by Prilenia at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sigma-1 Receptor Occupancy (time frame: 2 hours after oral administration of pridopidine). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03019289, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2021.