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| ID | Type | Description | Link |
|---|---|---|---|
| MK-8527-021 | Other Identifier | MSD |
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Researchers are studying a medicine called MK-8527 to learn how it behaves in the body of healthy adults.
The goal of this study is to learn about the effect of MK-8527 when it is taken with food or with other medicines. Researchers also want to learn about the safety of MK-8527 and if people tolerate it. Tolerate means participants will receive treatment in the trial unless they need to stop it due to health problems.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: MK-8527 | Experimental | Participants will receive a single dose of MK-8527 with food and a single dose of MK-8527 without food. |
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| Part 2: MK-8527 + Probenecid | Experimental | Participants will receive a single dose of MK-8527 alone and a single dose of MK-8527 in combination with probenecid. |
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| Part 3: MK-8527 + Itraconazole | Experimental | Participants will receive a single dose of MK-8527 alone and a single dose of MK-8527 in combination with itraconazole. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-8527 | Drug | Oral tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Area Under the Concentration Time Curve From Time 0 to Infinity (AUC0-inf) of MK-8527 in Plasma With and Without Food | Blood samples will be collected at multiple time points to estimate AUC0-inf of MK-8527 in plasma. | Predose and at designated timepoints (up to 336 hours postdose) |
| Part 2: AUC0-inf of MK-8527 in Plasma With and Without Probenecid | Blood samples will be collected at multiple time points to estimate AUC0-inf of MK-8527 in plasma. | Predose and at designated timepoints (up to 336 hours postdose) |
| Part 3: AUC0-inf of MK-8527 in Plasma With and Without Itraconazole | Blood samples will be collected at multiple time points to estimate AUC0-inf of MK-8527 in plasma. | Predose and at designated timepoints (up to 336 hours postdose) |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Area Under the Concentration Time Curve From Time 0 to 336 Hours (AUC0-336) of MK-8527 in Plasma With and Without Food | Blood samples will be collected at multiple time points to estimate AUC0-336 of MK-8527 in plasma. | Predose and at designated timepoints (up to 336 hours postdose) |
| Part 1: Time to Maximum Plasma Concentration (Tmax) of MK-8527 in Plasma With and Without Food |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Toll Free Number | Contact | 1-888-577-8839 | Trialsites@msd.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fortrea Clinical Research Unit Inc ( Site 0001) | Recruiting | Daytona Beach | Florida | 32117 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| ID | Term |
|---|---|
| D011339 | Probenecid |
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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| Probenecid | Drug | Oral tablet |
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| Itraconazole | Drug | Oral solution |
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Blood samples will be collected to estimate the Tmax of MK-8527 in plasma. |
| Predose and at designated timepoints (up to 336 hours postdose) |
| Part 1: Maximum Plasma Concentration (Cmax) of MK-8527 in Plasma With and Without Food | Blood samples will be collected to estimate the Cmax of MK-8527 in plasma. | Predose and at designated timepoints (up to 336 hours postdose) |
| Part 1: Apparent Terminal Half-life (t1/2) of MK-8527 in Plasma With and Without Food | Blood samples will be collected to estimate the apparent terminal t1/2 of MK-8527 in plasma. | Predose and at designated timepoints (up to 336 hours postdose) |
| Part 1: 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 AE will be reported. | Up to approximately 43 days |
| Part 1: Number of Participants Who Discontinue Study Treatment 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 treatment due to an AE will be reported. | Up to approximately 43 days |
| Part 2: AUC0-336 of MK-8527 in Plasma With and Without Probenecid | Blood samples will be collected to estimate the AUC0-336 of MK-8527 in plasma. | Predose and at designated timepoints (up to 336 hours postdose) |
| Part 2: Tmax of MK-8527 in Plasma with and without Probenecid | Blood samples will be collected to estimate the Tmax of MK-8527 in plasma. | Predose and at designated timepoints (up to 336 hours postdose) |
| Part 2: Cmax of MK-8527 in Plasma With and Without Probenecid | Blood samples will be collected to estimate the Cmax of MK-8527 in plasma. | Predose and at designated timepoints (up to 336 hours postdose) |
| Part 2: Apparent Terminal t1/2 of MK-8527 in Plasma With and Without Probenecid | Blood samples will be collected to estimate the apparent terminal t1/2 of MK-8527 in plasma. | Predose and at designated timepoints (up to 336 hours postdose) |
| Part 2: Urine Concentration at 72 Hours of MK-8527 | Urine samples will be collected to estimate the urine concentration of MK-8527. | At designated timepoints (up to 72 hours postdose) |
| Part 2: Renal Clearance of MK-8527 | Urine samples will be collected to estimate the renal clearance of MK-8527. | At designated timepoints (up to 72 hours postdose) |
| Part 2: Number of Participants Who Experience 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 experience AE will be reported. | Up to approximately 43 days |
| Part 2: Number of Participants Who Discontinue Study Treatment 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 treatment due to an AE will be reported. | Up to approximately 43 days |
| Part 3: AUC0-336 of MK-8527 in Plasma With and Without Itraconazole | Blood samples will be collected at multiple time points to estimate AUC0-336 of MK-8527 in plasma. | Predose and at designated timepoints (up to 336 hours postdose) |
| Part 3: Tmax of MK-8527 in Plasma With and Without Itraconazole | Blood samples will be collected to estimate the Tmax of MK-8527 in plasma. | Predose and at designated timepoints (up to 336 hours postdose) |
| Part 3: Cmax of MK-8527 in Plasma With and Without Itraconazole | Blood samples will be collected to estimate the Cmax of MK-8527 in plasma. | Predose and at designated timepoints (up to 336 hours postdose) |
| Part 3: Apparent Terminal t1/2 of MK-8527 in Plasma With and Without Itraconazole | Blood samples will be collected to estimate the apparent t1/2 of MK-8527 in plasma. | Predose and at designated timepoints (up to 336 hours postdose) |
| Part 3: Urine Concentration at 72 Hours of MK-8527 | Urine samples will be collected to estimate the urine concentration of MK-8527. | At designated timepoints (up to 72 hours postdose) |
| Part 3: Renal Clearance of MK-8527 | Urine samples will be collected to estimate the renal clearance of MK-8527. | At designated timepoints (up to 72 hours postdose) |
| Part 3: Number of Participants Who Experience 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 experience AE will be reported. | Up to approximately 43 days |
| Part 3: Number of Participants Who Discontinue Study Treatment 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 treatment due to an AE will be reported. | Up to approximately 43 days |
| Sulfur Compounds |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010879 | Piperazines |