Trial · 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
NCT03019289, Phase 1, Completed, Prilenia; results first posted 2021-11-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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. Trials, record NCT03019289. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03019289
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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
- NCT number
- NCT03019289
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 23 participants, actual
- Lead sponsor
- Prilenia
- Conditions
- Health Volunteers, Huntington Disease
- Interventions
- pridopidine (90 mg)
- First posted
- 2017-01-12
- Last updated
- 2021-11-19
- Other registries' IDs
- eudract:2016-001757-41
- Results first posted
- 2021-11-16
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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 |
| Secondary | 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. |
| Other | Dopamine-2 Receptor Occupancy | 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 |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Sigma-1 Receptor Occupancy | 2 hours after oral administration of pridopidine | Patients enrolled and receiving pridopidine. Patients from Cohort B (receiving fallypride only) and Cohort 0 (no pridopidine treatment) were not included in the analysis | percentage of receptor occupancy | MEAN |
| SECONDARY | 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. | Patients enrolled who received pridopidine and had sufficient data to calculate at least 1 evaluable pharmacokinetic parameter for pridopidine. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | 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. | Patients enrolled who received pridopidine and had sufficient data to calculate at least 1 evaluable pharmacokinetic parameter for pridopidine | hours | MEDIAN |
| OTHER_PRE_SPECIFIED | Dopamine-2 Receptor Occupancy | 2 h after pridopidine dosing | Patients enrolled and treated | percent volume/volume | MEAN |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Sigma-1 Receptor Occupancy | A: Cohort 1: P90 + (S)-(-)-FPD; HV | 91.21 | Full Range 88.82 to 95.67 | percentage of receptor occupancy | |
| Sigma-1 Receptor Occupancy | A: Cohort 2: P45 + (S)-(-)-FPD; HV | 87.19 | Full Range 87.19 to 87.19 | percentage of receptor occupancy | |
| Sigma-1 Receptor Occupancy | A: Cohort 2: P22.5 + (S)-(-)-FPD; HV | 86.67 | Full Range 84.06 to 89.24 | percentage of receptor occupancy | |
| Sigma-1 Receptor Occupancy | A: Cohort 3: P5 + (S)-(-)-FPD; HV | 77.96 | Full Range 76.75 to 79.16 | percentage of receptor occupancy | |
| Sigma-1 Receptor Occupancy | A: Cohort 7: P1 + (S)-(-)-FPD; HV | 41.77 | Full Range 41.77 to 41.77 | percentage of receptor occupancy | |
| Sigma-1 Receptor Occupancy | A: Cohort 7: P0.5 + (S)-(-)-FPD; HV | 17.55 | Full Range 17.55 to 17.55 | percentage of receptor occupancy | |
| Sigma-1 Receptor Occupancy | A: Cohort 6; P90 + (S)-(-)-FPD; HD | 87.37 | Full Range 80.36 to 93.23 | percentage of receptor occupancy | |
| Maximum Plasma Concentration of Pridopidine | A: Cohort 1: P90 + (S)-(-)-FPD; HV | 552 | Full Range 496 to 614 | ng/mL | |
| Maximum Plasma Concentration of Pridopidine | A: Cohort 2: P45 + (S)-(-)-FPD; HV | 307 | Full Range 307 to 307 | ng/mL | |
| Maximum Plasma Concentration of Pridopidine | A: Cohort 2: P22.5 + (S)-(-)-FPD; HV | 147 | Full Range 117 to 184 | ng/mL |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow27
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | A: Cohort 1: P90 + (S)-(-)-FPD; HV | 5 | |
| Overall Study | STARTED | A: Cohort 2: P45 + (S)-(-)-FPD; HV | 1 | |
| Overall Study | STARTED | A: Cohort 2: P22.5 + (S)-(-)-FPD; HV | 3 | |
| Overall Study | STARTED | A: Cohort 3: P5 + (S)-(-)-FPD; HV | 2 | |
| Overall Study | STARTED | A: Cohort 7: P1 + (S)-(-)-FPD; HV | 1 | |
| Overall Study | STARTED | A: Cohort 7: P0.5 + (S)-(-)-FPD; HV | 1 | |
| Overall Study | STARTED | A: Cohort 6; P90 + (S)-(-)-FPD; HD | 3 | |
| Overall Study | STARTED | B: Cohort 4: P90 + Fallypride; HV | 4 | |
| Overall Study | STARTED | Cohort 0: (S)-(-)-FPD, HV | 3 | |
| Overall Study | COMPLETED | A: Cohort 1: P90 + (S)-(-)-FPD; HV | 3 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 participant flowAdverse events126
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Vomiting | Gastrointestinal disorders | A: Cohort 1: P90 + (S)-(-)-FPD; HV | 0 | 5 | 0 |
| other | Vomiting | Gastrointestinal disorders | A: Cohort 2: P45 + (S)-(-)-FPD; HV | 0 | 1 | 0 |
| other | Vomiting | Gastrointestinal disorders | A: Cohort 2: P22.5 + (S)-(-)-FPD; HV | 0 | 3 | 0 |
| other | Vomiting | Gastrointestinal disorders | A: Cohort 3: P5 + (S)-(-)-FPD; HV | 0 | 2 | 0 |
| other | Vomiting | Gastrointestinal disorders | A: Cohort 7: P1 + (S)-(-)-FPD; HV | 0 | 1 | 0 |
| other | Vomiting | Gastrointestinal disorders | A: Cohort 7: P0.5 + (S)-(-)-FPD; HV | 0 | 1 | 0 |
| other | Vomiting | Gastrointestinal disorders | A: Cohort 6; P90 + (S)-(-)-FPD; HD | 0 | 3 | 0 |
| other | Vomiting | Gastrointestinal disorders | B: Cohort 4: P90 + Fallypride; HV | 1 | 4 | 1 |
| other | Vomiting | Gastrointestinal disorders | Cohort 0: (S)-(-)-FPD, HV | 1 | 3 | 1 |
| other | Catheter site hematoma | General disorders | A: Cohort 1: P90 + (S)-(-)-FPD; HV | 0 | 5 | 0 |
1 to 10 of 126Source ClinicalTrials.gov
See all 126 adverse eventsAdverse event totals27
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | A: Cohort 1: P90 + (S)-(-)-FPD; HV | 0 | 5 |
| Total, all-cause mortality | A: Cohort 2: P45 + (S)-(-)-FPD; HV | 0 | 1 |
| Total, all-cause mortality | A: Cohort 2: P22.5 + (S)-(-)-FPD; HV | 0 | 3 |
| Total, all-cause mortality | A: Cohort 3: P5 + (S)-(-)-FPD; HV | 0 | 2 |
| Total, all-cause mortality | A: Cohort 7: P1 + (S)-(-)-FPD; HV | 0 | 1 |
| Total, all-cause mortality | A: Cohort 7: P0.5 + (S)-(-)-FPD; HV | 0 | 1 |
| Total, all-cause mortality | A: Cohort 6; P90 + (S)-(-)-FPD; HD | 0 | 3 |
| Total, all-cause mortality | B: Cohort 4: P90 + Fallypride; HV | 0 | 4 |
| Total, all-cause mortality | Cohort 0: (S)-(-)-FPD, HV | 0 | 3 |
| Total, other adverse events | A: Cohort 1: P90 + (S)-(-)-FPD; HV | 2 | 5 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32995944 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03019289
GET https://conductscience.org/api/trials/v1/NCT03019289/results?page=2