Trial Outcomes & Findings for [11C]MK-6884 Positron Emission Tomography (PET) Tracer Validation Trial (MK-6884-001) (NCT NCT02621606)
NCT ID: NCT02621606
Last Updated: 2022-09-13
Results Overview
The number of participants experiencing an adverse event (AE) was assessed. An AE is defined as any unfavorable and unintended medical occurrence, sign, symptom, or disease temporally associated with the use of a pharmaceutical product or protocol-specified procedure, whether or not considered related to the pharmaceutical product or protocol-specified procedure. Any worsening of a preexisting condition, temporally associated with the use of the Sponsor's product, is also an AE.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
20 participants
Primary outcome timeframe
Up to 15 days
Results posted on
2022-09-13
Participant Flow
Healthy participants (Part 1), healthy elderly participants (Part 2), and participants with Alzheimer's Disease (AD; Part 3) were enrolled in this study.
N=20 participants were enrolled, with N=20 receiving ≥1 dose of \[11C\]MK-6884. N=1 participant in Part 2 withdrew from study before receiving the second dose of \[11C\]MK-6884.
Participant milestones
| Measure |
Part 1, Healthy Participants
Healthy participants receive a single intravenous (IV) dose of \~370 megabecquerel (MBq) \[11C\]MK-6884 in Part 1 of the study.
|
Part 2, Healthy Elderly Participants
Healthy elderly participants receive two separate IV doses of \~370 MBq \[11C\]MK-6884 in Part 2 of the study. Administration of the two doses is separated by at least 3 hours.
|
Part 3, Participants With AD
Participants with AD receive a single IV dose of \~370 MBq \[11C\]MK-6884 in Part 3 of the study.
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
7
|
10
|
|
Overall Study
Treated
|
3
|
7
|
10
|
|
Overall Study
COMPLETED
|
3
|
6
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Part 1, Healthy Participants
Healthy participants receive a single intravenous (IV) dose of \~370 megabecquerel (MBq) \[11C\]MK-6884 in Part 1 of the study.
|
Part 2, Healthy Elderly Participants
Healthy elderly participants receive two separate IV doses of \~370 MBq \[11C\]MK-6884 in Part 2 of the study. Administration of the two doses is separated by at least 3 hours.
|
Part 3, Participants With AD
Participants with AD receive a single IV dose of \~370 MBq \[11C\]MK-6884 in Part 3 of the study.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
Baseline Characteristics
[11C]MK-6884 Positron Emission Tomography (PET) Tracer Validation Trial (MK-6884-001)
Baseline characteristics by cohort
| Measure |
Part 1, Healthy Participants
n=3 Participants
Healthy participants receive a single IV dose of \~370 MBq \[11C\]MK-6884 in Part 1 of the study.
|
Part 2, Healthy Elderly Participants
n=7 Participants
Healthy elderly participants receive two separate IV doses of \~370 MBq \[11C\]MK-6884 in Part 2 of the study. Administration of the two doses is separated by at least 3 hours.
|
Part 3, Participants With AD
n=10 Participants
Participants with AD receive a single IV dose of \~370 MBq \[11C\]MK-6884 in Part 3 of the study.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
25.3 Years
STANDARD_DEVIATION 2.1 • n=5 Participants
|
62.6 Years
STANDARD_DEVIATION 5.4 • n=7 Participants
|
67.6 Years
STANDARD_DEVIATION 5.2 • n=5 Participants
|
59.5 Years
STANDARD_DEVIATION 15.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
12 Participants
n=4 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
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
19 Participants
n=4 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
|
|
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
|
PRIMARY outcome
Timeframe: Up to 15 daysPopulation: Includes all participants receiving ≥1 dose of \[11C\]MK-6884 in Parts 1, 2, or 3.
The number of participants experiencing an adverse event (AE) was assessed. An AE is defined as any unfavorable and unintended medical occurrence, sign, symptom, or disease temporally associated with the use of a pharmaceutical product or protocol-specified procedure, whether or not considered related to the pharmaceutical product or protocol-specified procedure. Any worsening of a preexisting condition, temporally associated with the use of the Sponsor's product, is also an AE.
Outcome measures
| Measure |
Part 1, Healthy Participants
n=3 Participants
Healthy participants receive a single IV dose of \~370 megabecquerel MBq \[11C\]MK-6884 in Part 1 of the study.
|
Part 2, Healthy Elderly Participants
n=7 Participants
Healthy elderly participants receive two separate IV doses of \~370 MBq \[11C\]MK-6884 in Part 2 of the study. Administration of the two doses is separated by at least 3 hours.
|
Part 3, Participants With AD
n=10 Participants
Participants with AD receive a single IV dose of \~370 MBq \[11C\]MK-6884 in Part 3 of the study.
|
|---|---|---|---|
|
Number of Participants Experiencing an Adverse Event (AE)
|
1 Participants
|
5 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 15 daysPopulation: Includes all participants receiving ≥1 dose of \[11C\]MK-6884 in Parts 1, 2, or 3.
The number of participants discontinuing the study due to an AE was assessed. An AE is defined as any unfavorable and unintended medical occurrence, sign, symptom, or disease temporally associated with the use of a pharmaceutical product or protocol-specified procedure, whether or not considered related to the pharmaceutical product or protocol-specified procedure. Any worsening of a preexisting condition, temporally associated with the use of the Sponsor's product, is also an AE.
Outcome measures
| Measure |
Part 1, Healthy Participants
n=3 Participants
Healthy participants receive a single IV dose of \~370 megabecquerel MBq \[11C\]MK-6884 in Part 1 of the study.
|
Part 2, Healthy Elderly Participants
n=7 Participants
Healthy elderly participants receive two separate IV doses of \~370 MBq \[11C\]MK-6884 in Part 2 of the study. Administration of the two doses is separated by at least 3 hours.
|
Part 3, Participants With AD
n=10 Participants
Participants with AD receive a single IV dose of \~370 MBq \[11C\]MK-6884 in Part 3 of the study.
|
|---|---|---|---|
|
Number of Participants Discontinuing the Study Due to an Adverse Event (AE)
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 2 hours post-dosePopulation: Includes only healthy participants in Part 1 (N=3). Per protocol, participants in Parts 2 and 3 were not tested for ED of \[11C\]MK-6884 and are excluded.
Mean effective dose (ED) of \[11C\]MK-6884 was calculated as a measure of risk associated with exposure of the whole body (WB) to low levels of ionizing radiation. Following \[11C\]MK-6884 injection, WB positron emission tomography (PET) scans were collected to visually identify organs absorbing \[11C\]MK-6884 in significant amounts. Around identified organs, three-dimensional (3D) volumes were drawn to estimate the percentage of injected activity absorbed. These data were converted into time-activity curves (TACs) and retention of radioactivity in these regions was entered into a human biodistribution model to determine ED of \[11C\]MK-6884. ED is expressed in units millisieverts (mSv) / MBq.
Outcome measures
| Measure |
Part 1, Healthy Participants
n=3 Participants
Healthy participants receive a single IV dose of \~370 megabecquerel MBq \[11C\]MK-6884 in Part 1 of the study.
|
Part 2, Healthy Elderly Participants
Healthy elderly participants receive two separate IV doses of \~370 MBq \[11C\]MK-6884 in Part 2 of the study. Administration of the two doses is separated by at least 3 hours.
|
Part 3, Participants With AD
Participants with AD receive a single IV dose of \~370 MBq \[11C\]MK-6884 in Part 3 of the study.
|
|---|---|---|---|
|
[Part 1] Mean Effective Dose of [11C]MK-6884
|
0.0072 mSv / MBq
Standard Deviation 0.00127
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 2 hours post dosePopulation: Includes only healthy participants in Part 1 (N=3), having estimable data for the individual organ. Per protocol, participants in Parts 2 and 3 were not tested for organ ED of \[11C\]MK-6884 and are excluded.
Mean organ ED of \[11C\]MK-6884 was calculated as a measure of risk associated with exposure of individual organs to low levels of ionizing radiation. Following \[11C\]MK-6884 injection, WB PET scans were collected to visually identify organs absorbing \[11C\]MK-6884 in significant amounts. Around identified organs, 3D volumes were drawn to estimate the percentage of injected activity absorbed. These data were converted into TACs and retention of radioactivity in these regions was used to calculate organ-specific ED of \[11C\]MK-6884. For sex organs (testes/ovaries), organ EDs were derived for participants of the respective sex. However, organ ED for the uterus was estimable in all participants as the male radiologic phantom was sufficiently hermaphroditic.
Outcome measures
| Measure |
Part 1, Healthy Participants
n=3 Participants
Healthy participants receive a single IV dose of \~370 megabecquerel MBq \[11C\]MK-6884 in Part 1 of the study.
|
Part 2, Healthy Elderly Participants
Healthy elderly participants receive two separate IV doses of \~370 MBq \[11C\]MK-6884 in Part 2 of the study. Administration of the two doses is separated by at least 3 hours.
|
Part 3, Participants With AD
Participants with AD receive a single IV dose of \~370 MBq \[11C\]MK-6884 in Part 3 of the study.
|
|---|---|---|---|
|
[Part 1] Mean Organ Effective Dose of [11C]MK-6884
Adrenals
|
0.00000924 mSv / MBq
Standard Deviation 0.0000019
|
—
|
—
|
|
[Part 1] Mean Organ Effective Dose of [11C]MK-6884
Brain
|
0.00000666 mSv / MBq
Standard Deviation 0.00000135
|
—
|
—
|
|
[Part 1] Mean Organ Effective Dose of [11C]MK-6884
Breasts
|
0.0000804 mSv / MBq
Standard Deviation 0.0000212
|
—
|
—
|
|
[Part 1] Mean Organ Effective Dose of [11C]MK-6884
Gallbladder Wall
|
0 mSv / MBq
Standard Deviation 0
|
—
|
—
|
|
[Part 1] Mean Organ Effective Dose of [11C]MK-6884
Lower Large Intestine Wall
|
0.000499 mSv / MBq
Standard Deviation 0.000146
|
—
|
—
|
|
[Part 1] Mean Organ Effective Dose of [11C]MK-6884
Small Intestine
|
0.000802 mSv / MBq
Standard Deviation 0.000217
|
—
|
—
|
|
[Part 1] Mean Organ Effective Dose of [11C]MK-6884
Stomach Wall
|
0.000357 mSv / MBq
Standard Deviation 0.0000962
|
—
|
—
|
|
[Part 1] Mean Organ Effective Dose of [11C]MK-6884
Upper Large Intestine Wall
|
0.0000312 mSv / MBq
Standard Deviation 0.00000782
|
—
|
—
|
|
[Part 1] Mean Organ Effective Dose of [11C]MK-6884
Heart Wall
|
0 mSv / MBq
Standard Deviation 0
|
—
|
—
|
|
[Part 1] Mean Organ Effective Dose of [11C]MK-6884
Kidneys
|
0.0000476 mSv / MBq
Standard Deviation 0.00000571
|
—
|
—
|
|
[Part 1] Mean Organ Effective Dose of [11C]MK-6884
Liver
|
0.00104 mSv / MBq
Standard Deviation 0.000236
|
—
|
—
|
|
[Part 1] Mean Organ Effective Dose of [11C]MK-6884
Lungs
|
0.000709 mSv / MBq
Standard Deviation 0.000228
|
—
|
—
|
|
[Part 1] Mean Organ Effective Dose of [11C]MK-6884
Muscle
|
0.00000541 mSv / MBq
Standard Deviation 0.00000144
|
—
|
—
|
|
[Part 1] Mean Organ Effective Dose of [11C]MK-6884
Ovaries (Female Participants Only)
|
0.00126 mSv / MBq
Standard Deviation 0
|
—
|
—
|
|
[Part 1] Mean Organ Effective Dose of [11C]MK-6884
Pancreas
|
0.00000938 mSv / MBq
Standard Deviation 0.00000215
|
—
|
—
|
|
[Part 1] Mean Organ Effective Dose of [11C]MK-6884
Red Marrow
|
0.000541 mSv / MBq
Standard Deviation 0.0000553
|
—
|
—
|
|
[Part 1] Mean Organ Effective Dose of [11C]MK-6884
Osteogenic Cells
|
0.000041 mSv / MBq
Standard Deviation 0.0000106
|
—
|
—
|
|
[Part 1] Mean Organ Effective Dose of [11C]MK-6884
Skin
|
0.0000145 mSv / MBq
Standard Deviation 0.00000409
|
—
|
—
|
|
[Part 1] Mean Organ Effective Dose of [11C]MK-6884
Spleen
|
0.0000256 mSv / MBq
Standard Deviation 0.0000202
|
—
|
—
|
|
[Part 1] Mean Organ Effective Dose of [11C]MK-6884
Testes (Male Participants Only)
|
0.0017 mSv / MBq
Standard Deviation 0.000573
|
—
|
—
|
|
[Part 1] Mean Organ Effective Dose of [11C]MK-6884
Thymus
|
0.00000463 mSv / MBq
Standard Deviation 0.00000118
|
—
|
—
|
|
[Part 1] Mean Organ Effective Dose of [11C]MK-6884
Thyroid
|
0.0000732 mSv / MBq
Standard Deviation 0.0000218
|
—
|
—
|
|
[Part 1] Mean Organ Effective Dose of [11C]MK-6884
Urinary Bladder Wall
|
0.00135 mSv / MBq
Standard Deviation 0.00045
|
—
|
—
|
|
[Part 1] Mean Organ Effective Dose of [11C]MK-6884
Uterus
|
0.0000124 mSv / MBq
Standard Deviation 0.00000334
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 90 minutes post dosePopulation: Includes only healthy elderly participants in Part 2 receiving 2 doses of \[11C\]MK-6884 who sufficiently comply with study protocol (N=6). Per protocol, participants in Part 1 were not tested for mean BPND of \[11C\]MK-6884 and are excluded. Mean BPND data for Part 3 participants are presented in a separate table.
Mean BPND of \[11C\]MK-6884 in each brain ROI was assessed. BPND is the ratio at equilibrium of specifically bound \[11C\]MK-6884 to that of non-displaceable \[11C\]MK-6884 in tissue. At time "0", a single IV bolus of \[11\]MK-6884 is administered and PET scanning initiated, yielding brain regional TACs. These TACs are then used to determine peak standard uptake value (SUV) and area under the curve (AUC) in order to quantify brain regional \[11C\]MK-6884 uptake. The target region BPND is estimated using the cerebellum as the reference region with the transient equilibrium tissue ratio (TE-TR) method. Higher values indicate increased specific \[11C\]MK-6884 binding in the brain ROI.
Outcome measures
| Measure |
Part 1, Healthy Participants
Healthy participants receive a single IV dose of \~370 megabecquerel MBq \[11C\]MK-6884 in Part 1 of the study.
|
Part 2, Healthy Elderly Participants
n=6 Participants
Healthy elderly participants receive two separate IV doses of \~370 MBq \[11C\]MK-6884 in Part 2 of the study. Administration of the two doses is separated by at least 3 hours.
|
Part 3, Participants With AD
Participants with AD receive a single IV dose of \~370 MBq \[11C\]MK-6884 in Part 3 of the study.
|
|---|---|---|---|
|
[Part 2] Mean Non-displaceable Binding Potential (BPND) of [11C]MK-6884 in Brain Regions of Interest (ROI)
Putamen
|
—
|
1.15 Ratio
Standard Deviation 0.14
|
—
|
|
[Part 2] Mean Non-displaceable Binding Potential (BPND) of [11C]MK-6884 in Brain Regions of Interest (ROI)
Striatum
|
—
|
0.96 Ratio
Standard Deviation 0.13
|
—
|
|
[Part 2] Mean Non-displaceable Binding Potential (BPND) of [11C]MK-6884 in Brain Regions of Interest (ROI)
Frontal Cortex
|
—
|
0.92 Ratio
Standard Deviation 0.15
|
—
|
|
[Part 2] Mean Non-displaceable Binding Potential (BPND) of [11C]MK-6884 in Brain Regions of Interest (ROI)
Temporal Cortex
|
—
|
0.92 Ratio
Standard Deviation 0.12
|
—
|
|
[Part 2] Mean Non-displaceable Binding Potential (BPND) of [11C]MK-6884 in Brain Regions of Interest (ROI)
Hippocampus
|
—
|
0.45 Ratio
Standard Deviation 0.11
|
—
|
PRIMARY outcome
Timeframe: Up to 24 hours post dosePopulation: Includes only healthy elderly participants in Part 2 receiving 2 doses of \[11C\]MK-6884 who sufficiently comply with study protocol (N=6). Per protocol, participants in Parts 1 and 3 were not tested for intra-subject T-RT variability of BPND of \[11C\]MK-6884 and are excluded.
Intra-subject T-RT variability in BPND of \[11C\]MK-6884 in each brain ROI was assessed. For each healthy elderly participant receiving 2 doses of \[11C\]MK-6884 in study Part 2, the BPND calculated during the first dose (BPND-1) was compared to the BPND calculated during the second dose (BPND-2) to determine the percent T-RT variability of the BPND of \[11C\]MK-6884 for each brain ROI. Percent T-RT variability = \[absolute value (BPND-1 - BPND-2) / (average BPND)\] \* 100. A percent T-RT variability = 0, indicates no variability between BPND-1 and BPND-2.
Outcome measures
| Measure |
Part 1, Healthy Participants
Healthy participants receive a single IV dose of \~370 megabecquerel MBq \[11C\]MK-6884 in Part 1 of the study.
|
Part 2, Healthy Elderly Participants
n=6 Participants
Healthy elderly participants receive two separate IV doses of \~370 MBq \[11C\]MK-6884 in Part 2 of the study. Administration of the two doses is separated by at least 3 hours.
|
Part 3, Participants With AD
Participants with AD receive a single IV dose of \~370 MBq \[11C\]MK-6884 in Part 3 of the study.
|
|---|---|---|---|
|
[Part 2] Intra-subject Test-Retest (T-RT) Variability of Non-displaceable Binding Potential (BPND) of [11C]MK-6884 in Brain Regions of Interest (ROI)
Putamen
|
—
|
14.1 Percent variability
Standard Deviation 9.0
|
—
|
|
[Part 2] Intra-subject Test-Retest (T-RT) Variability of Non-displaceable Binding Potential (BPND) of [11C]MK-6884 in Brain Regions of Interest (ROI)
Striatum
|
—
|
11.1 Percent variability
Standard Deviation 9.2
|
—
|
|
[Part 2] Intra-subject Test-Retest (T-RT) Variability of Non-displaceable Binding Potential (BPND) of [11C]MK-6884 in Brain Regions of Interest (ROI)
Frontal Cortex
|
—
|
16.0 Percent variability
Standard Deviation 7.8
|
—
|
|
[Part 2] Intra-subject Test-Retest (T-RT) Variability of Non-displaceable Binding Potential (BPND) of [11C]MK-6884 in Brain Regions of Interest (ROI)
Temporal Cortex
|
—
|
10.9 Percent variability
Standard Deviation 13.7
|
—
|
|
[Part 2] Intra-subject Test-Retest (T-RT) Variability of Non-displaceable Binding Potential (BPND) of [11C]MK-6884 in Brain Regions of Interest (ROI)
Hippocampus
|
—
|
24.9 Percent variability
Standard Deviation 15.3
|
—
|
PRIMARY outcome
Timeframe: Up to 90 minutes post dosePopulation: Includes only participants with AD in Part 3 receiving \[11C\]MK-6884 who sufficiently comply with study protocol (N=10). Per protocol, participants in Part 1 were not tested for mean BPND of \[11C\]MK-6884 and are excluded. Mean BPND data for Part 2 participants are presented in a separate table.
Mean BPND of \[11C\]MK-6884 in each brain ROI was assessed. BPND is the ratio at equilibrium of specifically bound \[11C\]MK-6884 to that of non-displaceable \[11C\]MK-6884 in tissue. At time "0", a single IV bolus of \[11\]MK-6884 is administered and PET scanning initiated, yielding brain regional TACs. These TACs are then used to determine SUV and AUC in order to quantify brain regional \[11C\]MK-6884 uptake. The target region BPND is estimated using the cerebellum as the reference region with the TE-TR method. Higher values indicate increased specific \[11C\]MK-6884 binding in the brain ROI.
Outcome measures
| Measure |
Part 1, Healthy Participants
Healthy participants receive a single IV dose of \~370 megabecquerel MBq \[11C\]MK-6884 in Part 1 of the study.
|
Part 2, Healthy Elderly Participants
Healthy elderly participants receive two separate IV doses of \~370 MBq \[11C\]MK-6884 in Part 2 of the study. Administration of the two doses is separated by at least 3 hours.
|
Part 3, Participants With AD
n=10 Participants
Participants with AD receive a single IV dose of \~370 MBq \[11C\]MK-6884 in Part 3 of the study.
|
|---|---|---|---|
|
[Part 3] Mean Regional Non-displaceable Binding Potential (BPND) of [11C]MK-6884 in Brain Regions of Interest
Frontal Cortex
|
—
|
—
|
0.74 Ratio
Standard Deviation 0.20
|
|
[Part 3] Mean Regional Non-displaceable Binding Potential (BPND) of [11C]MK-6884 in Brain Regions of Interest
Striatum
|
—
|
—
|
0.98 Ratio
Standard Deviation 0.20
|
Adverse Events
Part 1, Healthy Participants
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 2, Healthy Elderly Participants
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 3, Participants With AD
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part 1, Healthy Participants
n=3 participants at risk
Healthy participants receive a single IV dose of \~370 MBq \[11C\]MK-6884 in Part 1 of the study.
|
Part 2, Healthy Elderly Participants
n=7 participants at risk
Healthy elderly participants receive two separate IV doses of \~370 MBq \[11C\]MK-6884 in Part 2 of the study. Administration of the two doses is separated by at least 3 hours.
|
Part 3, Participants With AD
n=10 participants at risk
Participants with AD receive a single IV dose of \~370 MBq \[11C\]MK-6884 in Part 3 of the study.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/3 • Up to 15 days
An AE is defined as any unfavorable and unintended medical occurrence, sign, symptom, or disease temporally associated with the use of a pharmaceutical product or protocol-specified procedure, whether or not considered related to the pharmaceutical product or protocol-specified procedure. Any worsening of a preexisting condition, temporally associated with the use of the Sponsor's product, is also an AE. All participants receiving ≥1 dose of \[11C\]MK-6884 in study Parts 1, 2, or 3 are included.
|
14.3%
1/7 • Number of events 1 • Up to 15 days
An AE is defined as any unfavorable and unintended medical occurrence, sign, symptom, or disease temporally associated with the use of a pharmaceutical product or protocol-specified procedure, whether or not considered related to the pharmaceutical product or protocol-specified procedure. Any worsening of a preexisting condition, temporally associated with the use of the Sponsor's product, is also an AE. All participants receiving ≥1 dose of \[11C\]MK-6884 in study Parts 1, 2, or 3 are included.
|
0.00%
0/10 • Up to 15 days
An AE is defined as any unfavorable and unintended medical occurrence, sign, symptom, or disease temporally associated with the use of a pharmaceutical product or protocol-specified procedure, whether or not considered related to the pharmaceutical product or protocol-specified procedure. Any worsening of a preexisting condition, temporally associated with the use of the Sponsor's product, is also an AE. All participants receiving ≥1 dose of \[11C\]MK-6884 in study Parts 1, 2, or 3 are included.
|
Other adverse events
| Measure |
Part 1, Healthy Participants
n=3 participants at risk
Healthy participants receive a single IV dose of \~370 MBq \[11C\]MK-6884 in Part 1 of the study.
|
Part 2, Healthy Elderly Participants
n=7 participants at risk
Healthy elderly participants receive two separate IV doses of \~370 MBq \[11C\]MK-6884 in Part 2 of the study. Administration of the two doses is separated by at least 3 hours.
|
Part 3, Participants With AD
n=10 participants at risk
Participants with AD receive a single IV dose of \~370 MBq \[11C\]MK-6884 in Part 3 of the study.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
33.3%
1/3 • Number of events 1 • Up to 15 days
An AE is defined as any unfavorable and unintended medical occurrence, sign, symptom, or disease temporally associated with the use of a pharmaceutical product or protocol-specified procedure, whether or not considered related to the pharmaceutical product or protocol-specified procedure. Any worsening of a preexisting condition, temporally associated with the use of the Sponsor's product, is also an AE. All participants receiving ≥1 dose of \[11C\]MK-6884 in study Parts 1, 2, or 3 are included.
|
0.00%
0/7 • Up to 15 days
An AE is defined as any unfavorable and unintended medical occurrence, sign, symptom, or disease temporally associated with the use of a pharmaceutical product or protocol-specified procedure, whether or not considered related to the pharmaceutical product or protocol-specified procedure. Any worsening of a preexisting condition, temporally associated with the use of the Sponsor's product, is also an AE. All participants receiving ≥1 dose of \[11C\]MK-6884 in study Parts 1, 2, or 3 are included.
|
0.00%
0/10 • Up to 15 days
An AE is defined as any unfavorable and unintended medical occurrence, sign, symptom, or disease temporally associated with the use of a pharmaceutical product or protocol-specified procedure, whether or not considered related to the pharmaceutical product or protocol-specified procedure. Any worsening of a preexisting condition, temporally associated with the use of the Sponsor's product, is also an AE. All participants receiving ≥1 dose of \[11C\]MK-6884 in study Parts 1, 2, or 3 are included.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • Up to 15 days
An AE is defined as any unfavorable and unintended medical occurrence, sign, symptom, or disease temporally associated with the use of a pharmaceutical product or protocol-specified procedure, whether or not considered related to the pharmaceutical product or protocol-specified procedure. Any worsening of a preexisting condition, temporally associated with the use of the Sponsor's product, is also an AE. All participants receiving ≥1 dose of \[11C\]MK-6884 in study Parts 1, 2, or 3 are included.
|
0.00%
0/7 • Up to 15 days
An AE is defined as any unfavorable and unintended medical occurrence, sign, symptom, or disease temporally associated with the use of a pharmaceutical product or protocol-specified procedure, whether or not considered related to the pharmaceutical product or protocol-specified procedure. Any worsening of a preexisting condition, temporally associated with the use of the Sponsor's product, is also an AE. All participants receiving ≥1 dose of \[11C\]MK-6884 in study Parts 1, 2, or 3 are included.
|
10.0%
1/10 • Number of events 1 • Up to 15 days
An AE is defined as any unfavorable and unintended medical occurrence, sign, symptom, or disease temporally associated with the use of a pharmaceutical product or protocol-specified procedure, whether or not considered related to the pharmaceutical product or protocol-specified procedure. Any worsening of a preexisting condition, temporally associated with the use of the Sponsor's product, is also an AE. All participants receiving ≥1 dose of \[11C\]MK-6884 in study Parts 1, 2, or 3 are included.
|
|
Gastrointestinal disorders
Dyspepsia
|
33.3%
1/3 • Number of events 1 • Up to 15 days
An AE is defined as any unfavorable and unintended medical occurrence, sign, symptom, or disease temporally associated with the use of a pharmaceutical product or protocol-specified procedure, whether or not considered related to the pharmaceutical product or protocol-specified procedure. Any worsening of a preexisting condition, temporally associated with the use of the Sponsor's product, is also an AE. All participants receiving ≥1 dose of \[11C\]MK-6884 in study Parts 1, 2, or 3 are included.
|
0.00%
0/7 • Up to 15 days
An AE is defined as any unfavorable and unintended medical occurrence, sign, symptom, or disease temporally associated with the use of a pharmaceutical product or protocol-specified procedure, whether or not considered related to the pharmaceutical product or protocol-specified procedure. Any worsening of a preexisting condition, temporally associated with the use of the Sponsor's product, is also an AE. All participants receiving ≥1 dose of \[11C\]MK-6884 in study Parts 1, 2, or 3 are included.
|
0.00%
0/10 • Up to 15 days
An AE is defined as any unfavorable and unintended medical occurrence, sign, symptom, or disease temporally associated with the use of a pharmaceutical product or protocol-specified procedure, whether or not considered related to the pharmaceutical product or protocol-specified procedure. Any worsening of a preexisting condition, temporally associated with the use of the Sponsor's product, is also an AE. All participants receiving ≥1 dose of \[11C\]MK-6884 in study Parts 1, 2, or 3 are included.
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/3 • Up to 15 days
An AE is defined as any unfavorable and unintended medical occurrence, sign, symptom, or disease temporally associated with the use of a pharmaceutical product or protocol-specified procedure, whether or not considered related to the pharmaceutical product or protocol-specified procedure. Any worsening of a preexisting condition, temporally associated with the use of the Sponsor's product, is also an AE. All participants receiving ≥1 dose of \[11C\]MK-6884 in study Parts 1, 2, or 3 are included.
|
14.3%
1/7 • Number of events 1 • Up to 15 days
An AE is defined as any unfavorable and unintended medical occurrence, sign, symptom, or disease temporally associated with the use of a pharmaceutical product or protocol-specified procedure, whether or not considered related to the pharmaceutical product or protocol-specified procedure. Any worsening of a preexisting condition, temporally associated with the use of the Sponsor's product, is also an AE. All participants receiving ≥1 dose of \[11C\]MK-6884 in study Parts 1, 2, or 3 are included.
|
0.00%
0/10 • Up to 15 days
An AE is defined as any unfavorable and unintended medical occurrence, sign, symptom, or disease temporally associated with the use of a pharmaceutical product or protocol-specified procedure, whether or not considered related to the pharmaceutical product or protocol-specified procedure. Any worsening of a preexisting condition, temporally associated with the use of the Sponsor's product, is also an AE. All participants receiving ≥1 dose of \[11C\]MK-6884 in study Parts 1, 2, or 3 are included.
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/3 • Up to 15 days
An AE is defined as any unfavorable and unintended medical occurrence, sign, symptom, or disease temporally associated with the use of a pharmaceutical product or protocol-specified procedure, whether or not considered related to the pharmaceutical product or protocol-specified procedure. Any worsening of a preexisting condition, temporally associated with the use of the Sponsor's product, is also an AE. All participants receiving ≥1 dose of \[11C\]MK-6884 in study Parts 1, 2, or 3 are included.
|
14.3%
1/7 • Number of events 1 • Up to 15 days
An AE is defined as any unfavorable and unintended medical occurrence, sign, symptom, or disease temporally associated with the use of a pharmaceutical product or protocol-specified procedure, whether or not considered related to the pharmaceutical product or protocol-specified procedure. Any worsening of a preexisting condition, temporally associated with the use of the Sponsor's product, is also an AE. All participants receiving ≥1 dose of \[11C\]MK-6884 in study Parts 1, 2, or 3 are included.
|
0.00%
0/10 • Up to 15 days
An AE is defined as any unfavorable and unintended medical occurrence, sign, symptom, or disease temporally associated with the use of a pharmaceutical product or protocol-specified procedure, whether or not considered related to the pharmaceutical product or protocol-specified procedure. Any worsening of a preexisting condition, temporally associated with the use of the Sponsor's product, is also an AE. All participants receiving ≥1 dose of \[11C\]MK-6884 in study Parts 1, 2, or 3 are included.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1 • Up to 15 days
An AE is defined as any unfavorable and unintended medical occurrence, sign, symptom, or disease temporally associated with the use of a pharmaceutical product or protocol-specified procedure, whether or not considered related to the pharmaceutical product or protocol-specified procedure. Any worsening of a preexisting condition, temporally associated with the use of the Sponsor's product, is also an AE. All participants receiving ≥1 dose of \[11C\]MK-6884 in study Parts 1, 2, or 3 are included.
|
0.00%
0/7 • Up to 15 days
An AE is defined as any unfavorable and unintended medical occurrence, sign, symptom, or disease temporally associated with the use of a pharmaceutical product or protocol-specified procedure, whether or not considered related to the pharmaceutical product or protocol-specified procedure. Any worsening of a preexisting condition, temporally associated with the use of the Sponsor's product, is also an AE. All participants receiving ≥1 dose of \[11C\]MK-6884 in study Parts 1, 2, or 3 are included.
|
0.00%
0/10 • Up to 15 days
An AE is defined as any unfavorable and unintended medical occurrence, sign, symptom, or disease temporally associated with the use of a pharmaceutical product or protocol-specified procedure, whether or not considered related to the pharmaceutical product or protocol-specified procedure. Any worsening of a preexisting condition, temporally associated with the use of the Sponsor's product, is also an AE. All participants receiving ≥1 dose of \[11C\]MK-6884 in study Parts 1, 2, or 3 are included.
|
|
General disorders
Catheter site pain
|
0.00%
0/3 • Up to 15 days
An AE is defined as any unfavorable and unintended medical occurrence, sign, symptom, or disease temporally associated with the use of a pharmaceutical product or protocol-specified procedure, whether or not considered related to the pharmaceutical product or protocol-specified procedure. Any worsening of a preexisting condition, temporally associated with the use of the Sponsor's product, is also an AE. All participants receiving ≥1 dose of \[11C\]MK-6884 in study Parts 1, 2, or 3 are included.
|
14.3%
1/7 • Number of events 1 • Up to 15 days
An AE is defined as any unfavorable and unintended medical occurrence, sign, symptom, or disease temporally associated with the use of a pharmaceutical product or protocol-specified procedure, whether or not considered related to the pharmaceutical product or protocol-specified procedure. Any worsening of a preexisting condition, temporally associated with the use of the Sponsor's product, is also an AE. All participants receiving ≥1 dose of \[11C\]MK-6884 in study Parts 1, 2, or 3 are included.
|
0.00%
0/10 • Up to 15 days
An AE is defined as any unfavorable and unintended medical occurrence, sign, symptom, or disease temporally associated with the use of a pharmaceutical product or protocol-specified procedure, whether or not considered related to the pharmaceutical product or protocol-specified procedure. Any worsening of a preexisting condition, temporally associated with the use of the Sponsor's product, is also an AE. All participants receiving ≥1 dose of \[11C\]MK-6884 in study Parts 1, 2, or 3 are included.
|
|
General disorders
Influenza like illness
|
0.00%
0/3 • Up to 15 days
An AE is defined as any unfavorable and unintended medical occurrence, sign, symptom, or disease temporally associated with the use of a pharmaceutical product or protocol-specified procedure, whether or not considered related to the pharmaceutical product or protocol-specified procedure. Any worsening of a preexisting condition, temporally associated with the use of the Sponsor's product, is also an AE. All participants receiving ≥1 dose of \[11C\]MK-6884 in study Parts 1, 2, or 3 are included.
|
14.3%
1/7 • Number of events 1 • Up to 15 days
An AE is defined as any unfavorable and unintended medical occurrence, sign, symptom, or disease temporally associated with the use of a pharmaceutical product or protocol-specified procedure, whether or not considered related to the pharmaceutical product or protocol-specified procedure. Any worsening of a preexisting condition, temporally associated with the use of the Sponsor's product, is also an AE. All participants receiving ≥1 dose of \[11C\]MK-6884 in study Parts 1, 2, or 3 are included.
|
0.00%
0/10 • Up to 15 days
An AE is defined as any unfavorable and unintended medical occurrence, sign, symptom, or disease temporally associated with the use of a pharmaceutical product or protocol-specified procedure, whether or not considered related to the pharmaceutical product or protocol-specified procedure. Any worsening of a preexisting condition, temporally associated with the use of the Sponsor's product, is also an AE. All participants receiving ≥1 dose of \[11C\]MK-6884 in study Parts 1, 2, or 3 are included.
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.00%
0/3 • Up to 15 days
An AE is defined as any unfavorable and unintended medical occurrence, sign, symptom, or disease temporally associated with the use of a pharmaceutical product or protocol-specified procedure, whether or not considered related to the pharmaceutical product or protocol-specified procedure. Any worsening of a preexisting condition, temporally associated with the use of the Sponsor's product, is also an AE. All participants receiving ≥1 dose of \[11C\]MK-6884 in study Parts 1, 2, or 3 are included.
|
14.3%
1/7 • Number of events 1 • Up to 15 days
An AE is defined as any unfavorable and unintended medical occurrence, sign, symptom, or disease temporally associated with the use of a pharmaceutical product or protocol-specified procedure, whether or not considered related to the pharmaceutical product or protocol-specified procedure. Any worsening of a preexisting condition, temporally associated with the use of the Sponsor's product, is also an AE. All participants receiving ≥1 dose of \[11C\]MK-6884 in study Parts 1, 2, or 3 are included.
|
0.00%
0/10 • Up to 15 days
An AE is defined as any unfavorable and unintended medical occurrence, sign, symptom, or disease temporally associated with the use of a pharmaceutical product or protocol-specified procedure, whether or not considered related to the pharmaceutical product or protocol-specified procedure. Any worsening of a preexisting condition, temporally associated with the use of the Sponsor's product, is also an AE. All participants receiving ≥1 dose of \[11C\]MK-6884 in study Parts 1, 2, or 3 are included.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
1/3 • Number of events 1 • Up to 15 days
An AE is defined as any unfavorable and unintended medical occurrence, sign, symptom, or disease temporally associated with the use of a pharmaceutical product or protocol-specified procedure, whether or not considered related to the pharmaceutical product or protocol-specified procedure. Any worsening of a preexisting condition, temporally associated with the use of the Sponsor's product, is also an AE. All participants receiving ≥1 dose of \[11C\]MK-6884 in study Parts 1, 2, or 3 are included.
|
0.00%
0/7 • Up to 15 days
An AE is defined as any unfavorable and unintended medical occurrence, sign, symptom, or disease temporally associated with the use of a pharmaceutical product or protocol-specified procedure, whether or not considered related to the pharmaceutical product or protocol-specified procedure. Any worsening of a preexisting condition, temporally associated with the use of the Sponsor's product, is also an AE. All participants receiving ≥1 dose of \[11C\]MK-6884 in study Parts 1, 2, or 3 are included.
|
0.00%
0/10 • Up to 15 days
An AE is defined as any unfavorable and unintended medical occurrence, sign, symptom, or disease temporally associated with the use of a pharmaceutical product or protocol-specified procedure, whether or not considered related to the pharmaceutical product or protocol-specified procedure. Any worsening of a preexisting condition, temporally associated with the use of the Sponsor's product, is also an AE. All participants receiving ≥1 dose of \[11C\]MK-6884 in study Parts 1, 2, or 3 are included.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Up to 15 days
An AE is defined as any unfavorable and unintended medical occurrence, sign, symptom, or disease temporally associated with the use of a pharmaceutical product or protocol-specified procedure, whether or not considered related to the pharmaceutical product or protocol-specified procedure. Any worsening of a preexisting condition, temporally associated with the use of the Sponsor's product, is also an AE. All participants receiving ≥1 dose of \[11C\]MK-6884 in study Parts 1, 2, or 3 are included.
|
14.3%
1/7 • Number of events 1 • Up to 15 days
An AE is defined as any unfavorable and unintended medical occurrence, sign, symptom, or disease temporally associated with the use of a pharmaceutical product or protocol-specified procedure, whether or not considered related to the pharmaceutical product or protocol-specified procedure. Any worsening of a preexisting condition, temporally associated with the use of the Sponsor's product, is also an AE. All participants receiving ≥1 dose of \[11C\]MK-6884 in study Parts 1, 2, or 3 are included.
|
0.00%
0/10 • Up to 15 days
An AE is defined as any unfavorable and unintended medical occurrence, sign, symptom, or disease temporally associated with the use of a pharmaceutical product or protocol-specified procedure, whether or not considered related to the pharmaceutical product or protocol-specified procedure. Any worsening of a preexisting condition, temporally associated with the use of the Sponsor's product, is also an AE. All participants receiving ≥1 dose of \[11C\]MK-6884 in study Parts 1, 2, or 3 are included.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/3 • Up to 15 days
An AE is defined as any unfavorable and unintended medical occurrence, sign, symptom, or disease temporally associated with the use of a pharmaceutical product or protocol-specified procedure, whether or not considered related to the pharmaceutical product or protocol-specified procedure. Any worsening of a preexisting condition, temporally associated with the use of the Sponsor's product, is also an AE. All participants receiving ≥1 dose of \[11C\]MK-6884 in study Parts 1, 2, or 3 are included.
|
14.3%
1/7 • Number of events 1 • Up to 15 days
An AE is defined as any unfavorable and unintended medical occurrence, sign, symptom, or disease temporally associated with the use of a pharmaceutical product or protocol-specified procedure, whether or not considered related to the pharmaceutical product or protocol-specified procedure. Any worsening of a preexisting condition, temporally associated with the use of the Sponsor's product, is also an AE. All participants receiving ≥1 dose of \[11C\]MK-6884 in study Parts 1, 2, or 3 are included.
|
0.00%
0/10 • Up to 15 days
An AE is defined as any unfavorable and unintended medical occurrence, sign, symptom, or disease temporally associated with the use of a pharmaceutical product or protocol-specified procedure, whether or not considered related to the pharmaceutical product or protocol-specified procedure. Any worsening of a preexisting condition, temporally associated with the use of the Sponsor's product, is also an AE. All participants receiving ≥1 dose of \[11C\]MK-6884 in study Parts 1, 2, or 3 are included.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/3 • Up to 15 days
An AE is defined as any unfavorable and unintended medical occurrence, sign, symptom, or disease temporally associated with the use of a pharmaceutical product or protocol-specified procedure, whether or not considered related to the pharmaceutical product or protocol-specified procedure. Any worsening of a preexisting condition, temporally associated with the use of the Sponsor's product, is also an AE. All participants receiving ≥1 dose of \[11C\]MK-6884 in study Parts 1, 2, or 3 are included.
|
14.3%
1/7 • Number of events 1 • Up to 15 days
An AE is defined as any unfavorable and unintended medical occurrence, sign, symptom, or disease temporally associated with the use of a pharmaceutical product or protocol-specified procedure, whether or not considered related to the pharmaceutical product or protocol-specified procedure. Any worsening of a preexisting condition, temporally associated with the use of the Sponsor's product, is also an AE. All participants receiving ≥1 dose of \[11C\]MK-6884 in study Parts 1, 2, or 3 are included.
|
0.00%
0/10 • Up to 15 days
An AE is defined as any unfavorable and unintended medical occurrence, sign, symptom, or disease temporally associated with the use of a pharmaceutical product or protocol-specified procedure, whether or not considered related to the pharmaceutical product or protocol-specified procedure. Any worsening of a preexisting condition, temporally associated with the use of the Sponsor's product, is also an AE. All participants receiving ≥1 dose of \[11C\]MK-6884 in study Parts 1, 2, or 3 are included.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
- Publication restrictions are in place
Restriction type: OTHER