Trial Outcomes & Findings for Evaluating the Safety, Tolerability, Pharmacokinetics and Receptor Occupancy of BMS-984923 (NCT NCT04805983)
NCT ID: NCT04805983
Last Updated: 2024-08-27
Results Overview
A count of participants that experience any adverse events found to be associated with treatment. All adverse events are summarized in the adverse events section.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
36 participants
Primary outcome timeframe
Up to 7 days after last dose
Results posted on
2024-08-27
Participant Flow
Participant milestones
| Measure |
10 mg BMS-984923
BMS-984923: Day 1: Admission, administration of study drug, and 2 night in-patient stay; Day 3: Discharge following the completion of all scheduled procedures.
|
40 mg BMS-984923
BMS-984923: Day 1: Admission, administration of study drug, and 2 night in-patient stay; Day 3: Discharge following the completion of all scheduled procedures.
|
70 mg BMS-984923
BMS-984923: Day 1: Admission, administration of study drug, and 2 night in-patient stay; Day 3: Discharge following the completion of all scheduled procedures.
|
100 mg BMS-984923
BMS-984923: Day 1: Admission, administration of study drug, and 2 night in-patient stay; Day 3: Discharge following the completion of all scheduled procedures.
|
150 mg BMS-984923
BMS-984923: Day 1: Admission, administration of study drug, and 2 night in-patient stay; Day 3: Discharge following the completion of all scheduled procedures.
|
200 mg BMS-984923
BMS-984923: Day 1: Admission, administration of study drug, and 2 night in-patient stay; Day 3: Discharge following the completion of all scheduled procedures.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
Completed Baseline (Study Day 1)
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
Completed Inpatient Treatment (Study Day 3)
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
Completed In-Clinic Follow-Up (Study Day 4)
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
Completed Phone Visit Follow-Up (Study Day 5)
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
Completed In-Clinic Final Follow- Up/Completed Protocol (Study Day 7)
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluating the Safety, Tolerability, Pharmacokinetics and Receptor Occupancy of BMS-984923
Baseline characteristics by cohort
| Measure |
10 mg BMS-984923
n=6 Participants
BMS-984923: Day 1: Admission, administration of study drug, and 2 night in-patient stay; Day 3: Discharge following the completion of all scheduled procedures.
|
40 mg BMS-984923
n=6 Participants
BMS-984923: Day 1: Admission, administration of study drug, and 2 night in-patient stay; Day 3: Discharge following the completion of all scheduled procedures.
|
70 mg BMS-984923
n=6 Participants
BMS-984923: Day 1: Admission, administration of study drug, and 2 night in-patient stay; Day 3: Discharge following the completion of all scheduled procedures.
|
100 mg BMS-984923
n=6 Participants
BMS-984923: Day 1: Admission, administration of study drug, and 2 night in-patient stay; Day 3: Discharge following the completion of all scheduled procedures.
|
150 mg BMS-984923
n=6 Participants
BMS-984923: Day 1: Admission, administration of study drug, and 2 night in-patient stay; Day 3: Discharge following the completion of all scheduled procedures.
|
200 mg BMS-984923
n=6 Participants
BMS-984923: Day 1: Admission, administration of study drug, and 2 night in-patient stay; Day 3: Discharge following the completion of all scheduled procedures.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
70.9 years
STANDARD_DEVIATION 3.2 • n=5 Participants
|
71.3 years
STANDARD_DEVIATION 5.6 • n=7 Participants
|
70.3 years
STANDARD_DEVIATION 2.5 • n=5 Participants
|
68.3 years
STANDARD_DEVIATION 3.5 • n=4 Participants
|
72.8 years
STANDARD_DEVIATION 6.1 • n=21 Participants
|
68.1 years
STANDARD_DEVIATION 9.1 • n=8 Participants
|
70.3 years
STANDARD_DEVIATION 5.6 • n=8 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
21 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
15 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
33 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
35 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
6 participants
n=21 Participants
|
6 participants
n=8 Participants
|
36 participants
n=8 Participants
|
|
Body Mass Index (BMI)
|
26.5 kg/m^2
STANDARD_DEVIATION 4.6 • n=5 Participants
|
27.8 kg/m^2
STANDARD_DEVIATION 6.2 • n=7 Participants
|
24.8 kg/m^2
STANDARD_DEVIATION 3.3 • n=5 Participants
|
26.7 kg/m^2
STANDARD_DEVIATION 3.5 • n=4 Participants
|
26.0 kg/m^2
STANDARD_DEVIATION 2.2 • n=21 Participants
|
24.8 kg/m^2
STANDARD_DEVIATION 3.5 • n=8 Participants
|
26.1 kg/m^2
STANDARD_DEVIATION 3.9 • n=8 Participants
|
|
Logical Memory II Subscale, Delayed
|
14.2 units on a scale
STANDARD_DEVIATION 3.1 • n=5 Participants
|
13.8 units on a scale
STANDARD_DEVIATION 2.4 • n=7 Participants
|
11.2 units on a scale
STANDARD_DEVIATION 4.0 • n=5 Participants
|
11.3 units on a scale
STANDARD_DEVIATION 3.6 • n=4 Participants
|
13.2 units on a scale
STANDARD_DEVIATION 3.4 • n=21 Participants
|
13.8 units on a scale
STANDARD_DEVIATION 4.4 • n=8 Participants
|
12.9 units on a scale
STANDARD_DEVIATION 3.5 • n=8 Participants
|
|
Clinical Dementia Rating scale (CDR)
|
0 units on a scale
STANDARD_DEVIATION 0 • n=5 Participants
|
0 units on a scale
STANDARD_DEVIATION 0 • n=7 Participants
|
0 units on a scale
STANDARD_DEVIATION 0 • n=5 Participants
|
0 units on a scale
STANDARD_DEVIATION 0 • n=4 Participants
|
0 units on a scale
STANDARD_DEVIATION 0 • n=21 Participants
|
0 units on a scale
STANDARD_DEVIATION 0 • n=8 Participants
|
0 units on a scale
STANDARD_DEVIATION 0 • n=8 Participants
|
|
Mini Mental State Exam (MMSE)
|
29.3 units on a scale
STANDARD_DEVIATION 0.5 • n=5 Participants
|
28.8 units on a scale
STANDARD_DEVIATION 1.5 • n=7 Participants
|
29.5 units on a scale
STANDARD_DEVIATION 0.5 • n=5 Participants
|
29.0 units on a scale
STANDARD_DEVIATION 0.6 • n=4 Participants
|
29.5 units on a scale
STANDARD_DEVIATION 0.8 • n=21 Participants
|
29.5 units on a scale
STANDARD_DEVIATION 0.8 • n=8 Participants
|
29.3 units on a scale
STANDARD_DEVIATION 0.8 • n=8 Participants
|
|
Glasgow Coma Scale (GCS)
|
15.0 units on a scale
STANDARD_DEVIATION 0.0 • n=5 Participants
|
15.0 units on a scale
STANDARD_DEVIATION 0.0 • n=7 Participants
|
15.0 units on a scale
STANDARD_DEVIATION 0.0 • n=5 Participants
|
15.0 units on a scale
STANDARD_DEVIATION 0.0 • n=4 Participants
|
15.0 units on a scale
STANDARD_DEVIATION 0.0 • n=21 Participants
|
15.0 units on a scale
STANDARD_DEVIATION 0.0 • n=8 Participants
|
15.0 units on a scale
STANDARD_DEVIATION 0.0 • n=8 Participants
|
|
Geriatric Depression Scale (GDS)
|
0.0 units on a scale
STANDARD_DEVIATION 0.0 • n=5 Participants
|
0.3 units on a scale
STANDARD_DEVIATION 0.8 • n=7 Participants
|
1.5 units on a scale
STANDARD_DEVIATION 1.5 • n=5 Participants
|
0.8 units on a scale
STANDARD_DEVIATION 1.0 • n=4 Participants
|
1.2 units on a scale
STANDARD_DEVIATION 1.9 • n=21 Participants
|
1.0 units on a scale
STANDARD_DEVIATION 0.9 • n=8 Participants
|
0.8 units on a scale
STANDARD_DEVIATION 1.2 • n=8 Participants
|
|
Montreal Cognitive Assessment (MoCA)
|
28.2 units on a scale
STANDARD_DEVIATION 2.1 • n=5 Participants
|
26.8 units on a scale
STANDARD_DEVIATION 2.3 • n=7 Participants
|
26.5 units on a scale
STANDARD_DEVIATION 3.4 • n=5 Participants
|
26.0 units on a scale
STANDARD_DEVIATION 2.9 • n=4 Participants
|
27.5 units on a scale
STANDARD_DEVIATION 1.4 • n=21 Participants
|
27.2 units on a scale
STANDARD_DEVIATION 1.6 • n=8 Participants
|
27.0 units on a scale
STANDARD_DEVIATION 2.3 • n=8 Participants
|
PRIMARY outcome
Timeframe: Up to 7 days after last doseA count of participants that experience any adverse events found to be associated with treatment. All adverse events are summarized in the adverse events section.
Outcome measures
| Measure |
10 mg BMS-984923
n=6 Participants
BMS-984923: Day 1: Admission, administration of study drug, and 2 night in-patient stay; Day 3: Discharge following the completion of all scheduled procedures.
|
40 mg BMS-984923
n=6 Participants
BMS-984923: Day 1: Admission, administration of study drug, and 2 night in-patient stay; Day 3: Discharge following the completion of all scheduled procedures.
|
70 mg BMS-984923
n=6 Participants
BMS-984923: Day 1: Admission, administration of study drug, and 2 night in-patient stay; Day 3: Discharge following the completion of all scheduled procedures.
|
100 mg BMS-984923
n=6 Participants
BMS-984923: Day 1: Admission, administration of study drug, and 2 night in-patient stay; Day 3: Discharge following the completion of all scheduled procedures.
|
150 mg BMS-984923
n=6 Participants
BMS-984923: Day 1: Admission, administration of study drug, and 2 night in-patient stay; Day 3: Discharge following the completion of all scheduled procedures.
|
200 mg BMS-984923
n=6 Participants
BMS-984923: Day 1: Admission, administration of study drug, and 2 night in-patient stay; Day 3: Discharge following the completion of all scheduled procedures.
|
|---|---|---|---|---|---|---|
|
Count of Treatment Emergent Adverse Events (TEAEs)
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Up to 7 days after last doseCount of participants with clinical lab abnormalities.
Outcome measures
| Measure |
10 mg BMS-984923
n=6 Participants
BMS-984923: Day 1: Admission, administration of study drug, and 2 night in-patient stay; Day 3: Discharge following the completion of all scheduled procedures.
|
40 mg BMS-984923
n=6 Participants
BMS-984923: Day 1: Admission, administration of study drug, and 2 night in-patient stay; Day 3: Discharge following the completion of all scheduled procedures.
|
70 mg BMS-984923
n=6 Participants
BMS-984923: Day 1: Admission, administration of study drug, and 2 night in-patient stay; Day 3: Discharge following the completion of all scheduled procedures.
|
100 mg BMS-984923
n=6 Participants
BMS-984923: Day 1: Admission, administration of study drug, and 2 night in-patient stay; Day 3: Discharge following the completion of all scheduled procedures.
|
150 mg BMS-984923
n=6 Participants
BMS-984923: Day 1: Admission, administration of study drug, and 2 night in-patient stay; Day 3: Discharge following the completion of all scheduled procedures.
|
200 mg BMS-984923
n=6 Participants
BMS-984923: Day 1: Admission, administration of study drug, and 2 night in-patient stay; Day 3: Discharge following the completion of all scheduled procedures.
|
|---|---|---|---|---|---|---|
|
Count of Lab Abnormalities
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 7 days after last doseA count of participants that experienced any clinically significant changes in: Vital Signs, Physical Exam, Electrocardiogram, Neuropsychiatric Inventory - Q, Geriatric Depression Scale, Glasgow Coma Scale, Montreal Cognitive Assessment
Outcome measures
| Measure |
10 mg BMS-984923
n=6 Participants
BMS-984923: Day 1: Admission, administration of study drug, and 2 night in-patient stay; Day 3: Discharge following the completion of all scheduled procedures.
|
40 mg BMS-984923
n=6 Participants
BMS-984923: Day 1: Admission, administration of study drug, and 2 night in-patient stay; Day 3: Discharge following the completion of all scheduled procedures.
|
70 mg BMS-984923
n=6 Participants
BMS-984923: Day 1: Admission, administration of study drug, and 2 night in-patient stay; Day 3: Discharge following the completion of all scheduled procedures.
|
100 mg BMS-984923
n=6 Participants
BMS-984923: Day 1: Admission, administration of study drug, and 2 night in-patient stay; Day 3: Discharge following the completion of all scheduled procedures.
|
150 mg BMS-984923
n=6 Participants
BMS-984923: Day 1: Admission, administration of study drug, and 2 night in-patient stay; Day 3: Discharge following the completion of all scheduled procedures.
|
200 mg BMS-984923
n=6 Participants
BMS-984923: Day 1: Admission, administration of study drug, and 2 night in-patient stay; Day 3: Discharge following the completion of all scheduled procedures.
|
|---|---|---|---|---|---|---|
|
Count of Clinically Significant Changes in Safety Assessments
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 7 days after last doseMaximum plasma concentration as determined by pharmacokinetic modeling
Outcome measures
| Measure |
10 mg BMS-984923
n=6 Participants
BMS-984923: Day 1: Admission, administration of study drug, and 2 night in-patient stay; Day 3: Discharge following the completion of all scheduled procedures.
|
40 mg BMS-984923
n=6 Participants
BMS-984923: Day 1: Admission, administration of study drug, and 2 night in-patient stay; Day 3: Discharge following the completion of all scheduled procedures.
|
70 mg BMS-984923
n=6 Participants
BMS-984923: Day 1: Admission, administration of study drug, and 2 night in-patient stay; Day 3: Discharge following the completion of all scheduled procedures.
|
100 mg BMS-984923
n=6 Participants
BMS-984923: Day 1: Admission, administration of study drug, and 2 night in-patient stay; Day 3: Discharge following the completion of all scheduled procedures.
|
150 mg BMS-984923
n=6 Participants
BMS-984923: Day 1: Admission, administration of study drug, and 2 night in-patient stay; Day 3: Discharge following the completion of all scheduled procedures.
|
200 mg BMS-984923
n=6 Participants
BMS-984923: Day 1: Admission, administration of study drug, and 2 night in-patient stay; Day 3: Discharge following the completion of all scheduled procedures.
|
|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax)
|
21.86 ng/mL
Standard Deviation 7.85
|
189.15 ng/mL
Standard Deviation 82.18
|
293.22 ng/mL
Standard Deviation 150.56
|
125.85 ng/mL
Standard Deviation 62.72
|
480.83 ng/mL
Standard Deviation 235.19
|
455.65 ng/mL
Standard Deviation 167.88
|
PRIMARY outcome
Timeframe: Up to 7 days after last doseTime of Cmax as determined by pharmacokinetic modeling
Outcome measures
| Measure |
10 mg BMS-984923
n=6 Participants
BMS-984923: Day 1: Admission, administration of study drug, and 2 night in-patient stay; Day 3: Discharge following the completion of all scheduled procedures.
|
40 mg BMS-984923
n=6 Participants
BMS-984923: Day 1: Admission, administration of study drug, and 2 night in-patient stay; Day 3: Discharge following the completion of all scheduled procedures.
|
70 mg BMS-984923
n=6 Participants
BMS-984923: Day 1: Admission, administration of study drug, and 2 night in-patient stay; Day 3: Discharge following the completion of all scheduled procedures.
|
100 mg BMS-984923
n=6 Participants
BMS-984923: Day 1: Admission, administration of study drug, and 2 night in-patient stay; Day 3: Discharge following the completion of all scheduled procedures.
|
150 mg BMS-984923
n=6 Participants
BMS-984923: Day 1: Admission, administration of study drug, and 2 night in-patient stay; Day 3: Discharge following the completion of all scheduled procedures.
|
200 mg BMS-984923
n=6 Participants
BMS-984923: Day 1: Admission, administration of study drug, and 2 night in-patient stay; Day 3: Discharge following the completion of all scheduled procedures.
|
|---|---|---|---|---|---|---|
|
Time of Cmax (Tmax)
|
1.5 hours
Standard Deviation 0.548
|
1.67 hours
Standard Deviation 0.516
|
2.17 hours
Standard Deviation 1.472
|
2.17 hours
Standard Deviation 0.983
|
1.83 hours
Standard Deviation 0.408
|
3.33 hours
Standard Deviation 1.03
|
PRIMARY outcome
Timeframe: Up to 7 days after last dosePlasma drug exposure as determined by pharmacokinetic modeling, AUC is represented as ng∙h/mL.
Outcome measures
| Measure |
10 mg BMS-984923
n=6 Participants
BMS-984923: Day 1: Admission, administration of study drug, and 2 night in-patient stay; Day 3: Discharge following the completion of all scheduled procedures.
|
40 mg BMS-984923
n=6 Participants
BMS-984923: Day 1: Admission, administration of study drug, and 2 night in-patient stay; Day 3: Discharge following the completion of all scheduled procedures.
|
70 mg BMS-984923
n=6 Participants
BMS-984923: Day 1: Admission, administration of study drug, and 2 night in-patient stay; Day 3: Discharge following the completion of all scheduled procedures.
|
100 mg BMS-984923
n=6 Participants
BMS-984923: Day 1: Admission, administration of study drug, and 2 night in-patient stay; Day 3: Discharge following the completion of all scheduled procedures.
|
150 mg BMS-984923
n=6 Participants
BMS-984923: Day 1: Admission, administration of study drug, and 2 night in-patient stay; Day 3: Discharge following the completion of all scheduled procedures.
|
200 mg BMS-984923
n=6 Participants
BMS-984923: Day 1: Admission, administration of study drug, and 2 night in-patient stay; Day 3: Discharge following the completion of all scheduled procedures.
|
|---|---|---|---|---|---|---|
|
Area Under the Curve From 0 to 24h (AUC 24h)
|
105.29 ng∙h/mL
Standard Deviation 48.48
|
993.74 ng∙h/mL
Standard Deviation 345.23
|
1547.62 ng∙h/mL
Standard Deviation 765.72
|
967.56 ng∙h/mL
Standard Deviation 3130.23
|
3130.23 ng∙h/mL
Standard Deviation 1655.51
|
3752.1 ng∙h/mL
Standard Deviation 1259.84
|
SECONDARY outcome
Timeframe: Up to 24 hours after last dosePopulation: Receptor Occupancy is calculated as one value for all participants who underwent \[18F\]FPEB PET.
Metabotropic glutamate receptor subtype 5 (mGluR5) occupancy using \[18F\]FPEB Positron Emission Tomography calculated using the percentage of total mGluR5 availability and plasma concentrations of study drug were used to model the relationship between plasma concentration (CP) and receptor occupancy with the conventional sigmoidal maximum receptor occupancy (r\_max) model where IC50 is the CP required to produce 50% of the r\_max. A nonlinear least squares analysis was used to estimate the parameters from all scans. The data supported a model with 1 parameter (IC50, r\_max = 100%). IC80 is the CP required to produce 80% of the r\_max. The outcomes of relevance are the IC50 and IC80 calculated for the model.
Outcome measures
| Measure |
10 mg BMS-984923
n=8 Participants
BMS-984923: Day 1: Admission, administration of study drug, and 2 night in-patient stay; Day 3: Discharge following the completion of all scheduled procedures.
|
40 mg BMS-984923
BMS-984923: Day 1: Admission, administration of study drug, and 2 night in-patient stay; Day 3: Discharge following the completion of all scheduled procedures.
|
70 mg BMS-984923
BMS-984923: Day 1: Admission, administration of study drug, and 2 night in-patient stay; Day 3: Discharge following the completion of all scheduled procedures.
|
100 mg BMS-984923
BMS-984923: Day 1: Admission, administration of study drug, and 2 night in-patient stay; Day 3: Discharge following the completion of all scheduled procedures.
|
150 mg BMS-984923
BMS-984923: Day 1: Admission, administration of study drug, and 2 night in-patient stay; Day 3: Discharge following the completion of all scheduled procedures.
|
200 mg BMS-984923
BMS-984923: Day 1: Admission, administration of study drug, and 2 night in-patient stay; Day 3: Discharge following the completion of all scheduled procedures.
|
|---|---|---|---|---|---|---|
|
Receptor Occupancy
IC50
|
33.9 ng/mL
Standard Error 4
|
—
|
—
|
—
|
—
|
—
|
|
Receptor Occupancy
IC80
|
136.7 ng/mL
Standard Error 16
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
10 mg BMS-984923
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
40 mg BMS-984923
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
70 mg BMS-984923
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
100 mg BMS-984923
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
150 mg BMS-984923
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
200 mg BMS-984923
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 |
10 mg BMS-984923
n=6 participants at risk
BMS-984923: Day 1: Admission, administration of study drug, and 2 night in-patient stay; Day 3: Discharge following the completion of all scheduled procedures.
|
40 mg BMS-984923
n=6 participants at risk
BMS-984923: Day 1: Admission, administration of study drug, and 2 night in-patient stay; Day 3: Discharge following the completion of all scheduled procedures.
|
70 mg BMS-984923
n=6 participants at risk
BMS-984923: Day 1: Admission, administration of study drug, and 2 night in-patient stay; Day 3: Discharge following the completion of all scheduled procedures.
|
100 mg BMS-984923
n=6 participants at risk
BMS-984923: Day 1: Admission, administration of study drug, and 2 night in-patient stay; Day 3: Discharge following the completion of all scheduled procedures.
|
150 mg BMS-984923
n=6 participants at risk
BMS-984923: Day 1: Admission, administration of study drug, and 2 night in-patient stay; Day 3: Discharge following the completion of all scheduled procedures.
|
200 mg BMS-984923
n=6 participants at risk
BMS-984923: Day 1: Admission, administration of study drug, and 2 night in-patient stay; Day 3: Discharge following the completion of all scheduled procedures.
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Number of events 1 • Up to 7 days
|
0.00%
0/6 • Up to 7 days
|
0.00%
0/6 • Up to 7 days
|
16.7%
1/6 • Number of events 1 • Up to 7 days
|
16.7%
1/6 • Number of events 1 • Up to 7 days
|
0.00%
0/6 • Up to 7 days
|
|
Investigations
Blood triglycerides increased
|
16.7%
1/6 • Number of events 1 • Up to 7 days
|
0.00%
0/6 • Up to 7 days
|
0.00%
0/6 • Up to 7 days
|
0.00%
0/6 • Up to 7 days
|
0.00%
0/6 • Up to 7 days
|
0.00%
0/6 • Up to 7 days
|
|
Investigations
Blood pressure increased
|
16.7%
1/6 • Number of events 1 • Up to 7 days
|
0.00%
0/6 • Up to 7 days
|
0.00%
0/6 • Up to 7 days
|
0.00%
0/6 • Up to 7 days
|
0.00%
0/6 • Up to 7 days
|
0.00%
0/6 • Up to 7 days
|
|
General disorders
Infusion site bruising
|
0.00%
0/6 • Up to 7 days
|
16.7%
1/6 • Number of events 1 • Up to 7 days
|
0.00%
0/6 • Up to 7 days
|
16.7%
1/6 • Number of events 1 • Up to 7 days
|
0.00%
0/6 • Up to 7 days
|
0.00%
0/6 • Up to 7 days
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/6 • Up to 7 days
|
16.7%
1/6 • Number of events 1 • Up to 7 days
|
0.00%
0/6 • Up to 7 days
|
0.00%
0/6 • Up to 7 days
|
0.00%
0/6 • Up to 7 days
|
0.00%
0/6 • Up to 7 days
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/6 • Up to 7 days
|
16.7%
1/6 • Number of events 1 • Up to 7 days
|
0.00%
0/6 • Up to 7 days
|
0.00%
0/6 • Up to 7 days
|
0.00%
0/6 • Up to 7 days
|
0.00%
0/6 • Up to 7 days
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/6 • Up to 7 days
|
0.00%
0/6 • Up to 7 days
|
0.00%
0/6 • Up to 7 days
|
0.00%
0/6 • Up to 7 days
|
16.7%
1/6 • Number of events 1 • Up to 7 days
|
0.00%
0/6 • Up to 7 days
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6 • Up to 7 days
|
0.00%
0/6 • Up to 7 days
|
0.00%
0/6 • Up to 7 days
|
16.7%
1/6 • Number of events 1 • Up to 7 days
|
0.00%
0/6 • Up to 7 days
|
0.00%
0/6 • Up to 7 days
|
|
General disorders
Infusion site pain
|
0.00%
0/6 • Up to 7 days
|
0.00%
0/6 • Up to 7 days
|
0.00%
0/6 • Up to 7 days
|
16.7%
1/6 • Number of events 1 • Up to 7 days
|
0.00%
0/6 • Up to 7 days
|
0.00%
0/6 • Up to 7 days
|
|
General disorders
Infusion site discomfort
|
0.00%
0/6 • Up to 7 days
|
0.00%
0/6 • Up to 7 days
|
16.7%
1/6 • Number of events 1 • Up to 7 days
|
0.00%
0/6 • Up to 7 days
|
0.00%
0/6 • Up to 7 days
|
0.00%
0/6 • Up to 7 days
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6 • Up to 7 days
|
0.00%
0/6 • Up to 7 days
|
16.7%
1/6 • Number of events 1 • Up to 7 days
|
0.00%
0/6 • Up to 7 days
|
0.00%
0/6 • Up to 7 days
|
0.00%
0/6 • Up to 7 days
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Up to 7 days
|
0.00%
0/6 • Up to 7 days
|
0.00%
0/6 • Up to 7 days
|
0.00%
0/6 • Up to 7 days
|
16.7%
1/6 • Number of events 1 • Up to 7 days
|
0.00%
0/6 • Up to 7 days
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/6 • Up to 7 days
|
0.00%
0/6 • Up to 7 days
|
0.00%
0/6 • Up to 7 days
|
0.00%
0/6 • Up to 7 days
|
0.00%
0/6 • Up to 7 days
|
16.7%
1/6 • Number of events 1 • Up to 7 days
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/6 • Up to 7 days
|
0.00%
0/6 • Up to 7 days
|
0.00%
0/6 • Up to 7 days
|
0.00%
0/6 • Up to 7 days
|
0.00%
0/6 • Up to 7 days
|
16.7%
1/6 • Number of events 1 • Up to 7 days
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • Up to 7 days
|
0.00%
0/6 • Up to 7 days
|
0.00%
0/6 • Up to 7 days
|
0.00%
0/6 • Up to 7 days
|
0.00%
0/6 • Up to 7 days
|
16.7%
1/6 • Number of events 1 • Up to 7 days
|
Additional Information
Adam Mecca, MD, PhD
Associate Director of the Yale Alzheimer's Disease Research Unit
Phone: (203) 785-4736
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place