Trial Outcomes & Findings for 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 NCT03019289)
NCT ID: NCT03019289
Last Updated: 2021-11-19
Results Overview
Receptor occupancy of pridopidine to Sigma-1 receptors (S1R) in the brain was assessed from Positron Emission Tomography (PET) imaging with (S)-(-)-\[18F\]fluspidine
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
23 participants
Primary outcome timeframe
2 hours after oral administration of pridopidine
Results posted on
2021-11-19
Participant Flow
Healthy volunteers (HV) and patients with Huntington Disease (HD) were enrolled. The first participant was enrolled on 22 March 2017; the last subject completed the study on 09 February 2018.
The screening period had a duration of up to 8 weeks. A total of 49 healthy subjects and 3 HD patients were screened; of these, 20 healthy subjects and 3 HD patients met the eligibility criteria and were enrolled in the study.
Participant milestones
| Measure |
A: Cohort 1: P90 + (S)-(-)-FPD; HV
Healthy volunteers (HV) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer (S)-(-)-\[18F\]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
|
A: Cohort 2: P45 + (S)-(-)-FPD; HV
Healthy volunteers (HV) receiving a single dose of 45 mg pridopidine (P45) and radiolabeled PET tracer (S)-(-)-\[18F\]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
|
A: Cohort 2: P22.5 + (S)-(-)-FPD; HV
Healthy volunteers (HV) receiving a single dose of 22.5 mg pridopidine (P22.5) and radiolabeled PET tracer (S)-(-)-\[18F\]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
|
A: Cohort 3: P5 + (S)-(-)-FPD; HV
Healthy volunteers (HV) receiving a single dose of 5 mg pridopidine (P5) and radiolabeled PET tracer (S)-(-)-\[18F\]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
|
A: Cohort 7: P1 + (S)-(-)-FPD; HV
Healthy volunteers (HV) receiving a single dose of 1 mg pridopidine (P1) and radiolabeled PET tracer (S)-(-)-\[18F\]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
|
A: Cohort 7: P0.5 + (S)-(-)-FPD; HV
Healthy volunteers (HV) receiving a single dose of 0.5 mg pridopidine (P0.5) and radiolabeled PET tracer (S)-(-)-\[18F\]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
|
A: Cohort 6; P90 + (S)-(-)-FPD; HD
Patients with Huntington's Disease (HD) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer (S)-(-)-\[18F\]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
|
B: Cohort 4: P90 + Fallypride; HV
Healthy volunteers (HV) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer \[18F\]fallypride for neuroimaging in Part B of the study
|
Cohort 0: (S)-(-)-FPD, HV
Healthy volunteers (HV) receiving a single dose of radiolabeled PET tracer (S)-(-)-\[18F\]fluspidine ((S)-(-)-FPD) for neuroimaging
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
1
|
3
|
2
|
1
|
1
|
3
|
4
|
3
|
|
Overall Study
COMPLETED
|
3
|
1
|
3
|
2
|
1
|
1
|
3
|
4
|
2
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
A: Cohort 1: P90 + (S)-(-)-FPD; HV
Healthy volunteers (HV) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer (S)-(-)-\[18F\]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
|
A: Cohort 2: P45 + (S)-(-)-FPD; HV
Healthy volunteers (HV) receiving a single dose of 45 mg pridopidine (P45) and radiolabeled PET tracer (S)-(-)-\[18F\]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
|
A: Cohort 2: P22.5 + (S)-(-)-FPD; HV
Healthy volunteers (HV) receiving a single dose of 22.5 mg pridopidine (P22.5) and radiolabeled PET tracer (S)-(-)-\[18F\]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
|
A: Cohort 3: P5 + (S)-(-)-FPD; HV
Healthy volunteers (HV) receiving a single dose of 5 mg pridopidine (P5) and radiolabeled PET tracer (S)-(-)-\[18F\]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
|
A: Cohort 7: P1 + (S)-(-)-FPD; HV
Healthy volunteers (HV) receiving a single dose of 1 mg pridopidine (P1) and radiolabeled PET tracer (S)-(-)-\[18F\]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
|
A: Cohort 7: P0.5 + (S)-(-)-FPD; HV
Healthy volunteers (HV) receiving a single dose of 0.5 mg pridopidine (P0.5) and radiolabeled PET tracer (S)-(-)-\[18F\]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
|
A: Cohort 6; P90 + (S)-(-)-FPD; HD
Patients with Huntington's Disease (HD) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer (S)-(-)-\[18F\]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
|
B: Cohort 4: P90 + Fallypride; HV
Healthy volunteers (HV) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer \[18F\]fallypride for neuroimaging in Part B of the study
|
Cohort 0: (S)-(-)-FPD, HV
Healthy volunteers (HV) receiving a single dose of radiolabeled PET tracer (S)-(-)-\[18F\]fluspidine ((S)-(-)-FPD) for neuroimaging
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Other
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
A: Cohort 1: P90 + (S)-(-)-FPD; HV
n=5 Participants
Healthy volunteers (HV) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer (S)-(-)-\[18F\]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
|
A: Cohort 2: P45 + (S)-(-)-FPD; HV
n=1 Participants
Healthy volunteers (HV) receiving a single dose of 45 mg pridopidine (P45) and radiolabeled PET tracer (S)-(-)-\[18F\]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
|
A: Cohort 2: P22.5 + (S)-(-)-FPD; HV
n=3 Participants
Healthy volunteers (HV) receiving a single dose of 22.5 mg pridopidine (P22.5) and radiolabeled PET tracer (S)-(-)-\[18F\]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
|
A: Cohort 3: P5 + (S)-(-)-FPD; HV
n=2 Participants
Healthy volunteers (HV) receiving a single dose of 5 mg pridopidine (P5) and radiolabeled PET tracer (S)-(-)-\[18F\]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
|
A: Cohort 7: P1 + (S)-(-)-FPD; HV
n=1 Participants
Healthy volunteers (HV) receiving a single dose of 1 mg pridopidine (P1) and radiolabeled PET tracer (S)-(-)-\[18F\]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
|
A: Cohort 7: P0.5 + (S)-(-)-FPD; HV
n=1 Participants
Healthy volunteers (HV) receiving a single dose of 0.5 mg pridopidine (P0.5) and radiolabeled PET tracer (S)-(-)-\[18F\]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
|
A: Cohort 6; P90 + (S)-(-)-FPD; HD
n=3 Participants
Patients with Huntington's Disease (HD) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer (S)-(-)-\[18F\]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
|
B: Cohort 4: P90 + Fallypride; HV
n=4 Participants
Healthy volunteers (HV) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer \[18F\]fallypride for neuroimaging in Part B of the study
|
Cohort 0: (S)-(-)-FPD, HV
n=3 Participants
Healthy volunteers (HV) receiving a single dose of radiolabeled PET tracer (S)-(-)-\[18F\]fluspidine ((S)-(-)-FPD) for neuroimaging
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
28.0 years
n=99 Participants
|
26.0 years
n=107 Participants
|
25.0 years
n=206 Participants
|
27.5 years
n=7 Participants
|
30 years
n=31 Participants
|
25.0 years
n=30 Participants
|
40.0 years
n=3 Participants
|
28.0 years
n=6 Participants
|
29.0 years
n=114 Participants
|
28 years
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
3 Participants
n=114 Participants
|
23 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
|
Race/Ethnicity, Customized
White
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
22 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
1 Participants
|
|
Region of Enrollment
Germany
|
5 participants
n=99 Participants
|
1 participants
n=107 Participants
|
3 participants
n=206 Participants
|
2 participants
n=7 Participants
|
1 participants
n=31 Participants
|
1 participants
n=30 Participants
|
3 participants
n=3 Participants
|
4 participants
n=6 Participants
|
3 participants
n=114 Participants
|
23 participants
|
PRIMARY outcome
Timeframe: 2 hours after oral administration of pridopidinePopulation: Patients enrolled and receiving pridopidine. Patients from Cohort B (receiving fallypride only) and Cohort 0 (no pridopidine treatment) were not included in the analysis
Receptor occupancy of pridopidine to Sigma-1 receptors (S1R) in the brain was assessed from Positron Emission Tomography (PET) imaging with (S)-(-)-\[18F\]fluspidine
Outcome measures
| Measure |
A: Cohort 1: P90 + (S)-(-)-FPD; HV
n=3 Participants
Healthy volunteers (HV) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer (S)-(-)-\[18F\]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
|
A: Cohort 2: P45 + (S)-(-)-FPD; HV
n=1 Participants
Healthy volunteers (HV) receiving a single dose of 45 mg pridopidine (P45) and radiolabeled PET tracer (S)-(-)-\[18F\]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
|
A: Cohort 2: P22.5 + (S)-(-)-FPD; HV
n=3 Participants
Healthy volunteers (HV) receiving a single dose of 22.5 mg pridopidine (P22.5) and radiolabeled PET tracer (S)-(-)-\[18F\]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
|
A: Cohort 3: P5 + (S)-(-)-FPD; HV
n=2 Participants
Healthy volunteers (HV) receiving a single dose of 5 mg pridopidine (P5) and radiolabeled PET tracer (S)-(-)-\[18F\]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
|
A: Cohort 7: P1 + (S)-(-)-FPD; HV
n=1 Participants
Healthy volunteers (HV) receiving a single dose of 1 mg pridopidine (P1) and radiolabeled PET tracer (S)-(-)-\[18F\]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
|
A: Cohort 7: P0.5 + (S)-(-)-FPD; HV
n=1 Participants
Healthy volunteers (HV) receiving a single dose of 0.5 mg pridopidine (P0.5) and radiolabeled PET tracer (S)-(-)-\[18F\]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
|
A: Cohort 6; P90 + (S)-(-)-FPD; HD
n=3 Participants
Patients with Huntington's Disease (HD) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer (S)-(-)-\[18F\]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
|
B: Cohort 4: P90 + FPD; HV
Healthy volunteers (HV) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer \[18F\]fallypride for neuroimaging in Part B of the study
|
|---|---|---|---|---|---|---|---|---|
|
Sigma-1 Receptor Occupancy
|
91.21 percentage of receptor occupancy
Interval 88.82 to 95.67
|
87.19 percentage of receptor occupancy
Interval 87.19 to 87.19
|
86.67 percentage of receptor occupancy
Interval 84.06 to 89.24
|
77.96 percentage of receptor occupancy
Interval 76.75 to 79.16
|
41.77 percentage of receptor occupancy
Interval 41.77 to 41.77
|
17.55 percentage of receptor occupancy
Interval 17.55 to 17.55
|
87.37 percentage of receptor occupancy
Interval 80.36 to 93.23
|
—
|
SECONDARY outcome
Timeframe: 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.Population: Patients enrolled who received pridopidine and had sufficient data to calculate at least 1 evaluable pharmacokinetic parameter for pridopidine.
Maximum plasma concentration of pridopidine based on noncompartmental analysis
Outcome measures
| Measure |
A: Cohort 1: P90 + (S)-(-)-FPD; HV
n=3 Participants
Healthy volunteers (HV) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer (S)-(-)-\[18F\]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
|
A: Cohort 2: P45 + (S)-(-)-FPD; HV
n=1 Participants
Healthy volunteers (HV) receiving a single dose of 45 mg pridopidine (P45) and radiolabeled PET tracer (S)-(-)-\[18F\]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
|
A: Cohort 2: P22.5 + (S)-(-)-FPD; HV
n=3 Participants
Healthy volunteers (HV) receiving a single dose of 22.5 mg pridopidine (P22.5) and radiolabeled PET tracer (S)-(-)-\[18F\]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
|
A: Cohort 3: P5 + (S)-(-)-FPD; HV
n=2 Participants
Healthy volunteers (HV) receiving a single dose of 5 mg pridopidine (P5) and radiolabeled PET tracer (S)-(-)-\[18F\]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
|
A: Cohort 7: P1 + (S)-(-)-FPD; HV
n=1 Participants
Healthy volunteers (HV) receiving a single dose of 1 mg pridopidine (P1) and radiolabeled PET tracer (S)-(-)-\[18F\]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
|
A: Cohort 7: P0.5 + (S)-(-)-FPD; HV
n=1 Participants
Healthy volunteers (HV) receiving a single dose of 0.5 mg pridopidine (P0.5) and radiolabeled PET tracer (S)-(-)-\[18F\]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
|
A: Cohort 6; P90 + (S)-(-)-FPD; HD
n=3 Participants
Patients with Huntington's Disease (HD) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer (S)-(-)-\[18F\]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
|
B: Cohort 4: P90 + FPD; HV
n=4 Participants
Healthy volunteers (HV) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer \[18F\]fallypride for neuroimaging in Part B of the study
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration of Pridopidine
|
552 ng/mL
Interval 496.0 to 614.0
|
307 ng/mL
Interval 307.0 to 307.0
|
147 ng/mL
Interval 117.0 to 184.0
|
25.9 ng/mL
Interval 16.1 to 41.8
|
2.90 ng/mL
Interval 2.9 to 2.9
|
1.33 ng/mL
Interval 1.33 to 1.33
|
764 ng/mL
Interval 666.0 to 877.0
|
452 ng/mL
Interval 244.0 to 724.0
|
SECONDARY outcome
Timeframe: 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.Population: Patients enrolled who received pridopidine and had sufficient data to calculate at least 1 evaluable pharmacokinetic parameter for pridopidine
Multiple PK samples over 24 hours will be calculated for pridopidine and its metabolite TV-45065 in plasma using non-compartmental methods, when possible.
Outcome measures
| Measure |
A: Cohort 1: P90 + (S)-(-)-FPD; HV
n=3 Participants
Healthy volunteers (HV) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer (S)-(-)-\[18F\]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
|
A: Cohort 2: P45 + (S)-(-)-FPD; HV
n=1 Participants
Healthy volunteers (HV) receiving a single dose of 45 mg pridopidine (P45) and radiolabeled PET tracer (S)-(-)-\[18F\]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
|
A: Cohort 2: P22.5 + (S)-(-)-FPD; HV
n=3 Participants
Healthy volunteers (HV) receiving a single dose of 22.5 mg pridopidine (P22.5) and radiolabeled PET tracer (S)-(-)-\[18F\]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
|
A: Cohort 3: P5 + (S)-(-)-FPD; HV
n=2 Participants
Healthy volunteers (HV) receiving a single dose of 5 mg pridopidine (P5) and radiolabeled PET tracer (S)-(-)-\[18F\]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
|
A: Cohort 7: P1 + (S)-(-)-FPD; HV
n=1 Participants
Healthy volunteers (HV) receiving a single dose of 1 mg pridopidine (P1) and radiolabeled PET tracer (S)-(-)-\[18F\]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
|
A: Cohort 7: P0.5 + (S)-(-)-FPD; HV
n=1 Participants
Healthy volunteers (HV) receiving a single dose of 0.5 mg pridopidine (P0.5) and radiolabeled PET tracer (S)-(-)-\[18F\]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
|
A: Cohort 6; P90 + (S)-(-)-FPD; HD
n=3 Participants
Patients with Huntington's Disease (HD) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer (S)-(-)-\[18F\]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
|
B: Cohort 4: P90 + FPD; HV
n=4 Participants
Healthy volunteers (HV) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer \[18F\]fallypride for neuroimaging in Part B of the study
|
|---|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum (Peak) Concentration (Tmax)
|
1.97 hours
Interval 1.5 to 3.0
|
1.98 hours
Interval 1.98 to 1.98
|
1.00 hours
Interval 0.75 to 1.5
|
1.00 hours
Interval 0.75 to 1.5
|
1.98 hours
Interval 1.98 to 1.98
|
1.97 hours
Interval 1.97 to 1.97
|
1.00 hours
Interval 0.5 to 1.62
|
2.26 hours
Interval 1.0 to 5.02
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 h after pridopidine dosingPopulation: Patients enrolled and treated
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
Outcome measures
| Measure |
A: Cohort 1: P90 + (S)-(-)-FPD; HV
n=4 Participants
Healthy volunteers (HV) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer (S)-(-)-\[18F\]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
|
A: Cohort 2: P45 + (S)-(-)-FPD; HV
Healthy volunteers (HV) receiving a single dose of 45 mg pridopidine (P45) and radiolabeled PET tracer (S)-(-)-\[18F\]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
|
A: Cohort 2: P22.5 + (S)-(-)-FPD; HV
Healthy volunteers (HV) receiving a single dose of 22.5 mg pridopidine (P22.5) and radiolabeled PET tracer (S)-(-)-\[18F\]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
|
A: Cohort 3: P5 + (S)-(-)-FPD; HV
Healthy volunteers (HV) receiving a single dose of 5 mg pridopidine (P5) and radiolabeled PET tracer (S)-(-)-\[18F\]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
|
A: Cohort 7: P1 + (S)-(-)-FPD; HV
Healthy volunteers (HV) receiving a single dose of 1 mg pridopidine (P1) and radiolabeled PET tracer (S)-(-)-\[18F\]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
|
A: Cohort 7: P0.5 + (S)-(-)-FPD; HV
Healthy volunteers (HV) receiving a single dose of 0.5 mg pridopidine (P0.5) and radiolabeled PET tracer (S)-(-)-\[18F\]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
|
A: Cohort 6; P90 + (S)-(-)-FPD; HD
Patients with Huntington's Disease (HD) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer (S)-(-)-\[18F\]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
|
B: Cohort 4: P90 + FPD; HV
Healthy volunteers (HV) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer \[18F\]fallypride for neuroimaging in Part B of the study
|
|---|---|---|---|---|---|---|---|---|
|
Dopamine-2 Receptor Occupancy
|
3.34 percent volume/volume
Standard Deviation 2.05
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
A: Cohort 1: P90 + (S)-(-)-FPD; HV
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
A: Cohort 2: P45 + (S)-(-)-FPD; HV
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
A: Cohort 2: P22.5 + (S)-(-)-FPD; HV
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
A: Cohort 3: P5 + (S)-(-)-FPD; HV
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
A: Cohort 7: P1 + (S)-(-)-FPD; HV
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
A: Cohort 7: P0.5 + (S)-(-)-FPD; HV
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
A: Cohort 6; P90 + (S)-(-)-FPD; HD
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
B: Cohort 4: P90 + Fallypride; HV
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 0: (S)-(-)-FPD, HV
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
A: Cohort 1: P90 + (S)-(-)-FPD; HV
n=5 participants at risk
Healthy volunteers (HV) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer (S)-(-)-\[18F\]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
|
A: Cohort 2: P45 + (S)-(-)-FPD; HV
n=1 participants at risk
Healthy volunteers (HV) receiving a single dose of 45 mg pridopidine (P45) and radiolabeled PET tracer (S)-(-)-\[18F\]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
|
A: Cohort 2: P22.5 + (S)-(-)-FPD; HV
n=3 participants at risk
Healthy volunteers (HV) receiving a single dose of 22.5 mg pridopidine (P22.5) and radiolabeled PET tracer (S)-(-)-\[18F\]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
|
A: Cohort 3: P5 + (S)-(-)-FPD; HV
n=2 participants at risk
Healthy volunteers (HV) receiving a single dose of 5 mg pridopidine (P5) and radiolabeled PET tracer (S)-(-)-\[18F\]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
|
A: Cohort 7: P1 + (S)-(-)-FPD; HV
n=1 participants at risk
Healthy volunteers (HV) receiving a single dose of 1 mg pridopidine (P1) and radiolabeled PET tracer (S)-(-)-\[18F\]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
|
A: Cohort 7: P0.5 + (S)-(-)-FPD; HV
n=1 participants at risk
Healthy volunteers (HV) receiving a single dose of 0.5 mg pridopidine (P0.5) and radiolabeled PET tracer (S)-(-)-\[18F\]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
|
A: Cohort 6; P90 + (S)-(-)-FPD; HD
n=3 participants at risk
Patients with Huntington's Disease (HD) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer (S)-(-)-\[18F\]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
|
B: Cohort 4: P90 + Fallypride; HV
n=4 participants at risk
Healthy volunteers (HV) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer \[18F\]fallypride for neuroimaging in Part B of the study
|
Cohort 0: (S)-(-)-FPD, HV
n=3 participants at risk
Healthy volunteers (HV) receiving a single dose of radiolabeled PET tracer (S)-(-)-\[18F\]fluspidine ((S)-(-)-FPD) for neuroimaging
|
|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/5 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/1 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/3 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/2 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/1 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/1 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/3 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
25.0%
1/4 • Number of events 1 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
33.3%
1/3 • Number of events 1 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
|
General disorders
Catheter site hematoma
|
0.00%
0/5 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/1 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/3 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/2 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/1 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/1 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/3 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/4 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
100.0%
3/3 • Number of events 3 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
|
General disorders
Catheter site pain
|
0.00%
0/5 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/1 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/3 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/2 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/1 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/1 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/3 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/4 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
33.3%
1/3 • Number of events 1 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
|
General disorders
Catheter site paraesthisia
|
0.00%
0/5 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/1 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/3 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/2 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/1 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/1 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/3 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/4 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
33.3%
1/3 • Number of events 1 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/5 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/1 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/3 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/2 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/1 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/1 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/3 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/4 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
33.3%
1/3 • Number of events 1 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/5 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/1 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/3 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/2 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/1 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/1 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
33.3%
1/3 • Number of events 1 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/4 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/3 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/5 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/1 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/3 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/2 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/1 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/1 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
33.3%
1/3 • Number of events 1 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/4 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/3 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/5 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/1 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
33.3%
1/3 • Number of events 1 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/2 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/1 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/1 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/3 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/4 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/3 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
|
Injury, poisoning and procedural complications
Sports injury
|
0.00%
0/5 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/1 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
33.3%
1/3 • Number of events 1 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/2 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/1 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/1 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/3 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/4 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/3 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
|
Investigations
Haemoglobin decreased
|
40.0%
2/5 • Number of events 2 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
100.0%
1/1 • Number of events 1 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/3 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/2 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/1 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/1 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/3 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/4 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/3 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
|
Investigations
Haematocrit decreased
|
20.0%
1/5 • Number of events 1 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/1 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/3 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/2 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/1 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/1 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/3 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/4 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/3 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
|
Investigations
Red blood cell count decreased
|
20.0%
1/5 • Number of events 1 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/1 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/3 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/2 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/1 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/1 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/3 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/4 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/3 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/5 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/1 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/3 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/2 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/1 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/1 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/3 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/4 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
33.3%
1/3 • Number of events 1 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/5 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/1 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/3 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/2 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/1 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/1 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/3 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
25.0%
1/4 • Number of events 1 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
0.00%
0/3 • From signing of the informed consent through to 7 days after the last administration of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Data and results are owned by the sponsor. Results can be used by the institution for internal noncommercial research, education and patient care, and as required under applicable laws and regulations. Other uses require prior written consent of the sponsor.
- Publication restrictions are in place
Restriction type: OTHER