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Also known as [18F]MK-3328
MK-3328 · 1 trial · 1 indication
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug.
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug.
Using PET whole body images acquired after dosing, regions of interest (ROIs) were drawn in all organs showing visible \[18F\]MK-3328 accumulation. Time activity curves (TACs) showing total \[18F\]MK-3328 retention as a function of time were determined for each organ. Residence times were calculated from the area under each organ TAC. Radiation exposure of the body and critical organs was calculated from the \[18F\]MK-3328 residence times using OLINDA (Organ Level Internal Dose Assessment) software. For each organ, the equivalent dose, which is the absorbed radiation dose weighted for the degree of the biological effect of different types of radiation, was calculated. The total radiation exposure to the body is expressed as the effective dose, which is the sum of the equivalent doses in each organ multiplied by a weighting factor for the type of tissue exposed. Effective dose is the primary surrogate for radiation risk. The unit of effective dose is the Sievert (Sv).
Using PET whole body images acquired after dosing, ROIs were drawn in all organs showing visible \[18F\]MK-3328 accumulation. TACs showing total \[18F\]MK-3328 retention as a function of time were determined for each organ. Residence times were calculated from the area under each organ TAC. Radiation exposure of the body and critical organs was calculated from the \[18F\]MK-3328 residence times using OLINDA software. For each organ, the equivalent dose, which is the absorbed radiation dose weighted for the degree of the biological effect of different types of radiation, was calculated. The organ effective dose is the equivalent dose in each organ multiplied by a weighting factor for the type of tissue exposed. The unit of organ effective dose is Sv.
Using PET brain images acquired after dosing, regions of interest (ROIs) were drawn in identified brain areas. The ROIs were projected onto all frames of the dynamic PET scans in order to generate \[18F\]MK-3328 tissue TACs. SUVR is calculated as the ratio of the average \[18F\]MK-3328 uptake over 60-90 minutes post dose in the target brain region and the cerebellum. Cortical SUVR is reported, which is a mean SUVR derived from SUVR from multiple brain regions (frontal cortex, parietal cortex, anterior cingulate gyrus, posterior cingulate gyrus, temporal cortex, lateral temporal cortex and occipital cortices).
Using PET brain images acquired after the second dose of \[18F\]MK-3328, regions of interest (ROIs) were drawn in identified brain areas. The ROIs were projected onto all frames of the dynamic PET scans in order to generate \[18F\]MK-3328 tissue TACs. Posterior cingulate gyrus SUVR was calculated as the ratio of the average \[18F\]MK-3328 uptake over 60-90 minutes post dose in the target brain region and the cerebellum.
| Arm | Type | Description |
|---|---|---|
| Part I, Healthy Participants | EXPERIMENTAL | Healthy participants will receive a single intravenous (IV) dose of \~150 megabecquerel (MBq) \[18F\]MK-3328 in Part I of the study |
| Part II, HE and AD Participants | EXPERIMENTAL | HE and AD participants will receive a single IV dose of \~150 megabecquerel (MBq) \[18F\]MK-3328 in Part II of the study |
| Part III, HE and AD Participants | EXPERIMENTAL | HE and AD participants will receive two separate IV doses of \~150 megabecquerel (MBq) \[18F\]MK-3328 in Part III of the study |
| Name | Type | Description |
|---|---|---|
| [18F]MK-3328 | DRUG | IV dose of \~150 megabecquerel (MBq) \[18F\]MK-3328 |
Inclusion Criteria: Part I: * Participant is male or female of non-reproductive potential between 50 and 65 years old. * Participant is less than 6'5" tall * Participant is in good health * Participant has been a non-smoker for at least 10 years Parts II and III: * Male or female of non-reproduc...
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MK-3328 is an investigational small molecule being developed by Merck & Company, Inc. (MRK) for Alzheimer's disease. It is also known as [18F]MK-3328. It is a Phase 1 research-stage compound and has not been approved for any use.
MK-3328 is being studied in Alzheimer's disease as a PET imaging agent candidate. The single completed Phase 1 trial evaluated its safety, radiation dosimetry, biokinetics, and effectiveness in participants with Alzheimer's disease. It remains investigational and is not an approved treatment or diagnostic.
MK-3328 is developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker MRK. Merck sponsored the Phase 1 study of the compound. No other developer or partner is associated with the asset in the available record.
MK-3328 is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are currently listed. The compound is investigational and has not been approved by the FDA for any indication.
MK-3328 has been studied in one completed Phase 1 trial, NCT00954538, titled Safety, Radiation Dosimetry, Biokinetics, and Effectiveness of [18F]MK3328 (MK-3328-001). The trial enrolled 19 participants aged 50 years and older, including healthy volunteers, and used a controlled design without randomization or double blinding.
Yes. MK-3328 and [18F]MK-3328 refer to the same compound. The bracketed fluorine-18 label reflects the radiolabeled form used in the Phase 1 PET imaging study conducted by Merck in Alzheimer's disease. Searches for either name point to the same investigational asset.