Recent Updates
Recently added Catalysts

MK-6884

Phase 1

Alzheimer's Disease | Small molecule | Neurology |Merck & Company, Inc.|Last Updated: Sep 13, 2022

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02621606[11C]MK-6884 Positron Emission Tomography (PET) Tracer Validation Trial (MK-6884-001)PHASE1 COMPLETED 20Jan 8, 2016Dec 28, 2017Sep 13, 2022 -
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Number of Participants Experiencing an Adverse Event (AE)
Up to 15 days

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.

Number of Participants Discontinuing the Study Due to an Adverse Event (AE)
Up to 15 days

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.

[Part 1] Mean Effective Dose of [11C]MK-6884
Up to 2 hours post-dose

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.

[Part 1] Mean Organ Effective Dose of [11C]MK-6884
Up to 2 hours post dose

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.

[Part 2] Mean Non-displaceable Binding Potential (BPND) of [11C]MK-6884 in Brain Regions of Interest (ROI)
Up to 90 minutes post dose

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.

[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)
Up to 24 hours post dose

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.

[Part 3] Mean Regional Non-displaceable Binding Potential (BPND) of [11C]MK-6884 in Brain Regions of Interest
Up to 90 minutes post dose

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.

Unlock Study Endpoints
Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeOTHER
Treatment Arms
ArmTypeDescription
Part 1, Healthy ParticipantsEXPERIMENTALHealthy participants receive a single intravenous (IV) dose of \~370 megabecquerel (MBq) \[11C\]MK-6884 in Part 1 of the study.
Part 2, Healthy Elderly ParticipantsEXPERIMENTALHealthy 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 ADEXPERIMENTALParticipants with AD receive a single IV dose of \~370 MBq \[11C\]MK-6884 in Part 3 of the study.
Interventions
NameTypeDescription
[11C]MK-6884DRUGIV bolus dose of \~370 MBq \[11C\]MK-6884
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 85 Years
SexALL
Healthy VolunteersYes

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...

Unlock Eligibility Criteria