Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| MK-1708-003 | Other Identifier | MSD |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of the study is to see what happens to levels of MK-1708 a person's body over time. Researchers will compare what happens to MK-1708 in the body when it is given with or without a medicine called itraconazole.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period 1: MK-1708 | Experimental | Participants will receive a single oral dose of MK-1708 on Day 1. |
|
| Period 2: MK-1708 and Itraconazole | Experimental | A washout period of at least 10 days will occur between MK-1708 dosing in Period 1 and the first itraconazole dosing in Period 2. In Period 2, participants will receive itraconazole twice daily on Day 1 and once daily on Days 2 through Day 19. Participants will also receive a single oral dose of MK-1708 on Day 4. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-1708 | Drug | Oral administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-1708 | Blood samples will be collected to determine the AUC0-inf of MK-1708. | Predose and at designated timepoints up to approximately 2 weeks postdose |
| Number of Participants Who Experience an Adverse Event (AE) | An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported. | Up to approximately 11 weeks |
| Number of Participants Who Discontinue Study Due to an AE | An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study due to an AE will be reported. | Up to approximately 11 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve from Time 0 to Last Quantifiable Concentration (AUC0-Last) of MK-1708 | Blood samples will be collected to determine the AUC0-last of MK-1708. | Predose and at designated timepoints up to approximately 2 weeks postdose |
| Maximum Plasma Concentration (Cmax) of MK-1708 |
Not provided
Inclusion Criteria:
The key inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The key exclusion criteria include but are not limited to the following:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| QPS-MRA, LLC ( Site 0001) | South Miami | Florida | 33143 | United States |
Not provided
| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Itraconazole |
| Drug |
Oral administration |
|
Blood samples will be collected to determine the Cmax of MK-1708. |
| Predose and at designated timepoints up to approximately 2 weeks postdose |
| Time to Maximum Plasma Concentration (Tmax) of MK-1708 | Blood samples will be collected to determine the Tmax of MK-1708. | Predose and at designated timepoints up to approximately 2 weeks postdose |
| Plasma Concentration at 24 Hours (C24) of MK-1708 | Blood samples will be collected to determine the C24 of MK-1708. | Predose and at designated timepoints up to 24 hours postdose |
| Apparent Clearance (CL/F) of MK-1708 | Blood samples will be collected to determine the CL/F of MK-1708. | Predose and at designated timepoints up to approximately 2 weeks postdose |
| Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-1708 | Blood samples will be collected to determine the Vz/F of MK-1708. | Predose and at designated timepoints up to approximately 2 weeks postdose |
| Apparent Terminal Half-life (t1/2) of MK-1708 | Blood samples will be collected to determine the t1/2 of MK-1708. | Predose and at designated timepoints up to approximately 2 weeks postdose |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D010879 |
| Piperazines |