Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as [11C]MK-6884
MK-6884 · 1 trial · 1 indication
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.
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.
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.
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.
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| Part 1, Healthy Participants | EXPERIMENTAL | 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 | EXPERIMENTAL | 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 | EXPERIMENTAL | Participants with AD receive a single IV dose of \~370 MBq \[11C\]MK-6884 in Part 3 of the study. |
| Name | Type | Description |
|---|---|---|
| [11C]MK-6884 | DRUG | IV bolus dose of \~370 MBq \[11C\]MK-6884 |
Inclusion Criteria: Part 1, 2 and 3: * Male, or non-pregnant and non-breast feeding female of 18 to 55 years of age (Part 1) or 55 to 85 years of age (Parts 2 and 3); in addition: * Male participant who is sexually active with females of childbearing potential must be willing to use a condom fr...
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MK-6884 is an investigational small molecule developed by Merck & Company, Inc. (ticker MRK) as a positron emission tomography (PET) tracer. It is being studied in Alzheimer's disease and is also known as [11C]MK-6884. It is a Phase 1 research-stage agent, not an approved medicine.
MK-6884 is used as a PET imaging tracer in Alzheimer's disease research. The single completed Phase 1 trial, NCT02621606, evaluated it as a tracer validation study in participants with Alzheimer's disease and healthy volunteers. It is not a treatment for Alzheimer's disease and is not approved for clinical use.
MK-6884 is developed by Merck & Company, Inc., which trades under the ticker MRK. Merck sponsored the Phase 1 PET tracer validation trial, MK-6884-001, registered as NCT02621606. The compound is also referred to as [11C]MK-6884, reflecting its carbon-11 radiolabel used for imaging.
MK-6884 is in Phase 1 development. One Phase 1 trial has been completed, and no trials are currently active. The completed study, NCT02621606, was a PET tracer validation trial with 20 participants, including healthy volunteers, conducted in Alzheimer's disease. MK-6884 is investigational and has not been approved by the FDA.
MK-6884 has been studied in one clinical trial, NCT02621606, titled [11C]MK-6884 Positron Emission Tomography (PET) Tracer Validation Trial (MK-6884-001). The Phase 1 study enrolled 20 participants, included healthy volunteers and people with Alzheimer's disease, and is now completed. It was a controlled trial without randomization or double blinding.
Yes, MK-6884 and [11C]MK-6884 refer to the same compound. The bracketed carbon-11 label denotes the radiolabeled form used as a positron emission tomography tracer in the Phase 1 validation trial NCT02621606. Both names appear in the trial title, MK-6884-001, sponsored by Merck & Company, Inc.