Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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...
Top 20 of 24 competitors
MK-3328 is an investigational small molecule being studied for use in Alzheimer's Disease. It is currently in Phase 1 clinical development. The drug is being developed by Merck & Company, Inc. (ticker: MRK).
The molecular target of MK-3328 has not been disclosed in available clinical trial information. The drug is a small molecule being investigated for Alzheimer's Disease, but its specific mechanism of action is not publicly detailed.
MK-3328 is being developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker MRK. The company is conducting clinical research on this investigational small molecule for Alzheimer's Disease.
MK-3328 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The single Phase 1 trial for MK-3328 has been completed.
MK-3328 has one completed Phase 1 trial, NCT00954538, titled "Safety, Radiation Dosimetry, Biokinetics, and Effectiveness of [18F]MK3328 (MK-3328-001)." This trial enrolled 19 participants and included healthy volunteers aged 50 years and older.
Yes, MK-3328 is the same compound as [18F]MK3328. The clinical trial NCT00954538 refers to the drug as [18F]MK3328, indicating it is a fluorinated form of MK-3328 used for imaging or diagnostic purposes in the study.