Trial Outcomes & Findings for CRF - Nociceptin Receptor Interactions (NCT NCT03302416)
NCT ID: NCT03302416
Last Updated: 2020-10-27
Results Overview
VT is the volume of distribution expressed relative to total plasma concentration. This is defined consistent with that reported in Consensus nomenclature for in vivo imaging of reversibly binding radioligands (Reference: J Cereb Blood Flow Metab 2007 Sep;27(9):1533-9. doi: 10.1038/sj.jcbfm.9600493)
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
19 participants
Primary outcome timeframe
Baseline and 3.5 hours post-hydrocortisone
Results posted on
2020-10-27
Participant Flow
45 subjects screened, 19 assigned to interventions
Participant milestones
| Measure |
[C-11]NOP-1A PET Scan Conditions
Baseline condition and Post-hydrocortisone (1 mg/Kg, intravenous) condition
Hydrocortisone
\[C-11\]NOP-1A
|
|---|---|
|
Overall Study
STARTED
|
19
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CRF - Nociceptin Receptor Interactions
Baseline characteristics by cohort
| Measure |
[C-11]NOP-1A PET Scan Conditions
n=19 Participants
Baseline condition and Post-hydrocortisone (1 mg/Kg, intravenous) condition
Hydrocortisone
\[C-11\]NOP-1A
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
25 years
STANDARD_DEVIATION 4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 Participants
n=5 Participants
|
|
Weight
|
77 Kilograms
STANDARD_DEVIATION 16 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 3.5 hours post-hydrocortisoneVT is the volume of distribution expressed relative to total plasma concentration. This is defined consistent with that reported in Consensus nomenclature for in vivo imaging of reversibly binding radioligands (Reference: J Cereb Blood Flow Metab 2007 Sep;27(9):1533-9. doi: 10.1038/sj.jcbfm.9600493)
Outcome measures
| Measure |
Baseline Participants
n=19 Participants
Healthy Controls
|
|---|---|
|
[C-11]NOP-1A Volume of Distribution Expressed Relative to Total Plasma Concentration
Midbrain/baseline
|
9.4 mL/cm^3
Standard Deviation 1.0
|
|
[C-11]NOP-1A Volume of Distribution Expressed Relative to Total Plasma Concentration
Midbrain/post-hydrocortisone
|
10.6 mL/cm^3
Standard Deviation 1.6
|
|
[C-11]NOP-1A Volume of Distribution Expressed Relative to Total Plasma Concentration
Caudate/baseline
|
12.7 mL/cm^3
Standard Deviation 1.4
|
|
[C-11]NOP-1A Volume of Distribution Expressed Relative to Total Plasma Concentration
Caudate/post-hydrocortisone
|
14.0 mL/cm^3
Standard Deviation 1.9
|
|
[C-11]NOP-1A Volume of Distribution Expressed Relative to Total Plasma Concentration
MedialPFC/baseline
|
14.3 mL/cm^3
Standard Deviation 1.8
|
|
[C-11]NOP-1A Volume of Distribution Expressed Relative to Total Plasma Concentration
MedialPFC/post-hydrocortisone
|
16.2 mL/cm^3
Standard Deviation 2.4
|
|
[C-11]NOP-1A Volume of Distribution Expressed Relative to Total Plasma Concentration
anterior cigulate/baseline
|
14.6 mL/cm^3
Standard Deviation 1.7
|
|
[C-11]NOP-1A Volume of Distribution Expressed Relative to Total Plasma Concentration
Cerebellum/baseline
|
8.2 mL/cm^3
Standard Deviation 0.9
|
|
[C-11]NOP-1A Volume of Distribution Expressed Relative to Total Plasma Concentration
Cerebellum/post-hydrocortisone
|
9.3 mL/cm^3
Standard Deviation 1.3
|
|
[C-11]NOP-1A Volume of Distribution Expressed Relative to Total Plasma Concentration
Amygdala/baseline
|
16.3 mL/cm^3
Standard Deviation 1.9
|
|
[C-11]NOP-1A Volume of Distribution Expressed Relative to Total Plasma Concentration
Amygdala/post-hydrocortisone
|
18.7 mL/cm^3
Standard Deviation 2.8
|
|
[C-11]NOP-1A Volume of Distribution Expressed Relative to Total Plasma Concentration
Hippocampus/baseline
|
11.6 mL/cm^3
Standard Deviation 1.3
|
|
[C-11]NOP-1A Volume of Distribution Expressed Relative to Total Plasma Concentration
Hippocampus/post-hydrocortisone
|
13.3 mL/cm^3
Standard Deviation 2.0
|
|
[C-11]NOP-1A Volume of Distribution Expressed Relative to Total Plasma Concentration
Vental striatum/baseline
|
15.1 mL/cm^3
Standard Deviation 1.7
|
|
[C-11]NOP-1A Volume of Distribution Expressed Relative to Total Plasma Concentration
Ventral striatum/post-hydrocortisone
|
17.1 mL/cm^3
Standard Deviation 2.1
|
|
[C-11]NOP-1A Volume of Distribution Expressed Relative to Total Plasma Concentration
Putamen/baseline
|
14.3 mL/cm^3
Standard Deviation 1.6
|
|
[C-11]NOP-1A Volume of Distribution Expressed Relative to Total Plasma Concentration
Putamen/post-hydrocortisone
|
16.0 mL/cm^3
Standard Deviation 2.0
|
|
[C-11]NOP-1A Volume of Distribution Expressed Relative to Total Plasma Concentration
dorsolateralPFC/baseline
|
14.4 mL/cm^3
Standard Deviation 1.8
|
|
[C-11]NOP-1A Volume of Distribution Expressed Relative to Total Plasma Concentration
dorsolateralPFC/post-hydrocortisone
|
16.4 mL/cm^3
Standard Deviation 2.4
|
|
[C-11]NOP-1A Volume of Distribution Expressed Relative to Total Plasma Concentration
Orbital frontal cortex/baseline
|
14.9 mL/cm^3
Standard Deviation 1.8
|
|
[C-11]NOP-1A Volume of Distribution Expressed Relative to Total Plasma Concentration
Orbital frontal cortex/post-hydrocortisone
|
17.1 mL/cm^3
Standard Deviation 2.6
|
|
[C-11]NOP-1A Volume of Distribution Expressed Relative to Total Plasma Concentration
anterior cingulate/post-hydrocortisone
|
16.6 mL/cm^3
Standard Deviation 2.6
|
Adverse Events
[C-11]NOP-1A PET Scan Conditions
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place