Trial Outcomes & Findings for Title: Evaluation of a Novel PET Radioligand for Phosphodiesterase-4D (PDE4D) (NCT NCT03861000)
NCT ID: NCT03861000
Last Updated: 2021-03-22
Results Overview
To determine whether the uptake of 11C-T-1650 in brain reflects the distribution of PDE4D
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
3 participants
Primary outcome timeframe
120 minutes after the start of the first scan
Results posted on
2021-03-22
Participant Flow
A single subject was enrolled only for pre-study whole body dosimetry calculations.
Participant milestones
| Measure |
Brain PET Scan With 11C-T-1650 and Blocking With BPN14770
Baseline brain PET scan (scan 1) with 20 mCi of 11C-T-1650 given intravenously, followed by a second Brain PET scan (scan 2) 90-180 minutes after first dose administration of BPN14770 50mg given orally. A third brain PET scan (scan 3) is performed after the last dose of BPN14770. 20 mCi of 11C-T-1650 is given intravenously with each PET scan. BPN14770 50mg given orally twice a day for a total of seven doses. BPN14770 is a PDE4D-inhibitor.
|
Whole Body PET Scan With Intravenous 11C-T-1650
10 mCi of 11C-T-1650 given intravenously once followed by a Whole Body PET scan. This was done for whole body dosimetry calculations.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
1
|
|
Overall Study
COMPLETED
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Title: Evaluation of a Novel PET Radioligand for Phosphodiesterase-4D (PDE4D)
Baseline characteristics by cohort
| Measure |
Brain PET Scan With 11C-T-1650 and Blocking With BPN14770
n=2 Participants
Baseline brain PET scan (scan 1) with 20 mCi of 11C-T-1650 given intravenously, followed by a second Brain PET scan (scan 2) 90-180 minutes after first dose administration of BPN14770 50mg given orally. A third brain PET scan (scan 3) is performed after the last dose of BPN14770. 20 mCi of 11C-T-1650 is given intravenously with each PET scan. BPN14770 50mg given orally twice a day for a total of seven doses. BPN14770 is a PDE4D-inhibitor.
|
Whole Body PET Scan With Intravenous 11C-T-1650
n=1 Participants
10 mCi of 11C-T-1650 given intravenously once followed by a Whole Body PET scan. This was done for whole body dosimetry calculations.
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 120 minutes after the start of the first scanPopulation: The analyses included only those subjects who completed brain 11C-T-1650 and oral 50 mg BID of BPN14770 (twice/day, 7 times in total)
To determine whether the uptake of 11C-T-1650 in brain reflects the distribution of PDE4D
Outcome measures
| Measure |
Brain PET Scan With 11C-T-1650 and Blocking With BPN14770
n=2 Participants
Baseline brain PET scan (scan 1) with 20 mCi of 11C-T-1650 given intravenously, followed by a second Brain PET scan (scan 2) 90-180 minutes after first dose administration of BPN14770 50mg given orally. A third brain PET scan (scan 3) is performed after the last dose of BPN14770. 20 mCi of 11C-T-1650 is given intravenously with each PET scan. BPN14770 50mg given orally twice a day for a total of seven doses. BPN14770 is a PDE4D-inhibitor.
|
|---|---|
|
Whole Brain Total Distribution Volume (VT) - Baseline
|
8.2 mL x cm^3
Standard Deviation 0.91
|
PRIMARY outcome
Timeframe: 120 minutes after the start of the second scanPopulation: The analyses included only those subjects who completed brain 11C-T-1650 and oral 50 mg BID of BPN14770 (twice/day, 7 times in total)
To determine whether the uptake of 11C-T-1650 in brain reflects the distribution of PDE4D
Outcome measures
| Measure |
Brain PET Scan With 11C-T-1650 and Blocking With BPN14770
n=2 Participants
Baseline brain PET scan (scan 1) with 20 mCi of 11C-T-1650 given intravenously, followed by a second Brain PET scan (scan 2) 90-180 minutes after first dose administration of BPN14770 50mg given orally. A third brain PET scan (scan 3) is performed after the last dose of BPN14770. 20 mCi of 11C-T-1650 is given intravenously with each PET scan. BPN14770 50mg given orally twice a day for a total of seven doses. BPN14770 is a PDE4D-inhibitor.
|
|---|---|
|
Whole Brain Total Distribution Volume (VT)-1st Blocked
|
5.5 mL x cm^3
Standard Deviation 20.2
|
PRIMARY outcome
Timeframe: 120 minutes after the start of the scanPopulation: The analyses included only those subjects who completed brain 11C-T-1650 and oral 50 mg BID of BPN14770 (twice/day, 7 times in total)
Measure binding site occupancy of BPN14770 administered at doses that may be used in clinical trials.
Outcome measures
| Measure |
Brain PET Scan With 11C-T-1650 and Blocking With BPN14770
n=2 Participants
Baseline brain PET scan (scan 1) with 20 mCi of 11C-T-1650 given intravenously, followed by a second Brain PET scan (scan 2) 90-180 minutes after first dose administration of BPN14770 50mg given orally. A third brain PET scan (scan 3) is performed after the last dose of BPN14770. 20 mCi of 11C-T-1650 is given intravenously with each PET scan. BPN14770 50mg given orally twice a day for a total of seven doses. BPN14770 is a PDE4D-inhibitor.
|
|---|---|
|
Standard UptakeValue (SUV) Area Under the Curve (AUC) (60-120min)-Baseline Whole Brain
|
102.1 SUV x min
Standard Deviation 31.7
|
PRIMARY outcome
Timeframe: 120 minutes after the start of the first scanPopulation: The analyses included only those subjects who completed brain 11C-T-1650 and oral 50 mg BID of BPN14770 (twice/day, 7 times in total)
Measure binding site occupancy of BPN14770 administered at doses that may be used in clinical trials.
Outcome measures
| Measure |
Brain PET Scan With 11C-T-1650 and Blocking With BPN14770
n=2 Participants
Baseline brain PET scan (scan 1) with 20 mCi of 11C-T-1650 given intravenously, followed by a second Brain PET scan (scan 2) 90-180 minutes after first dose administration of BPN14770 50mg given orally. A third brain PET scan (scan 3) is performed after the last dose of BPN14770. 20 mCi of 11C-T-1650 is given intravenously with each PET scan. BPN14770 50mg given orally twice a day for a total of seven doses. BPN14770 is a PDE4D-inhibitor.
|
|---|---|
|
Standard UptakeValue (SUV) Area Under the Curve (AUC) (60-120min)-1st Blocked Whole Brain
|
71.719845 SUV x min
Standard Deviation 20.2
|
PRIMARY outcome
Timeframe: 120 minutes after the start of the first scanPopulation: The analyses included only those subjects who completed brain 11C-T-1650 and oral 50 mg BID of BPN14770 (twice/day, 7 times in total)
Measure binding site occupancy of BPN14770 administered at doses that may be used in clinical trials.
Outcome measures
| Measure |
Brain PET Scan With 11C-T-1650 and Blocking With BPN14770
n=2 Participants
Baseline brain PET scan (scan 1) with 20 mCi of 11C-T-1650 given intravenously, followed by a second Brain PET scan (scan 2) 90-180 minutes after first dose administration of BPN14770 50mg given orally. A third brain PET scan (scan 3) is performed after the last dose of BPN14770. 20 mCi of 11C-T-1650 is given intravenously with each PET scan. BPN14770 50mg given orally twice a day for a total of seven doses. BPN14770 is a PDE4D-inhibitor.
|
|---|---|
|
Standard UptakeValue (SUV) Area Under the Curve (AUC) (60-120min)-2nd Blocked Whole Brain
|
87.77384 SUV x min
Standard Deviation 19.7
|
Adverse Events
Brain PET Scan With 11C-T-1650 and Blocking With BPN14770
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Whole Body PET Scan With Intravenous 11C-T-1650
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Brain PET Scan With 11C-T-1650 and Blocking With BPN14770
n=2 participants at risk
Baseline brain PET scan (scan 1) with 20 mCi of 11C-T-1650 given intravenously, followed by a second Brain PET scan (scan 2) 90-180 minutes after first dose administration of BPN14770 50mg given orally. A third brain PET scan (scan 3) is performed after the last dose of BPN14770. 20 mCi of 11C-T-1650 is given intravenously with each PET scan. BPN14770 50mg given orally twice a day for a total of seven doses. BPN14770 is a PDE4D-inhibitor.
|
Whole Body PET Scan With Intravenous 11C-T-1650
n=1 participants at risk
10 mCi of 11C-T-1650 given intravenously once followed by a Whole Body PET scan. This was done for whole body dosimetry calculations.
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|---|---|---|
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Renal and urinary disorders
Polyuria
|
50.0%
1/2 • 24 hours
|
0.00%
0/1 • 24 hours
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place