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| ID | Type | Description | Link |
|---|---|---|---|
| MK-2828-007 | Other Identifier | MSD |
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The main goals of this study are:
Researchers want to learn if the levels of MK-2828 in the body are about the same when MK-2828 is taken with itraconazole as when it is taken alone. They also want to know if taking MK-2828 more than once affects how much midazolam is in the body after a single dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Itraconazole | Experimental | Participants will receive multiple oral doses of Itraconazole with a single oral dose of MK-2828. |
|
| Part 2: Midazolam | Experimental | Participants will receive multiple oral doses of MK-2828 with a single oral dose of midazolam. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-2828 | Drug | Administered orally as capsule |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1 (Itraconazole): Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of MK-2828 | Blood samples will be collected at multiple time points to determine the AUC0-inf of MK-2828. | Predose and at designated timepoints up to approximately 288 hours (hrs) postdose |
| Part 1 (Itraconazole): Maximum Plasma Concentration (Cmax) of MK-2828 | Blood samples will be collected at multiple time points to determine the Cmax of MK-2828. | Predose and at designated timepoints up to approximately 288 hrs postdose |
| Part 2 (Midazolam): Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Midazolam | Blood samples will be collected at multiple time points to determine the AUC0-inf of Midazolam. | Predose and at designated timepoints up to approximately 24hrs postdose |
| Part 2 (Midazolam): Maximum Plasma Concentration (Cmax) of Midazolam | Blood samples will be collected at multiple time points to determine the Cmax of Midazolam. | Predose and at designated timepoints up to approximately 24hrs postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1 (Itraconazole): Area Under the Curve From Time 0 to Last Quantifiable Sample (AUC0-last) of MK-2828 | Blood samples will be collected at multiple time points to determine the AUC0-last of MK-2828. | Predose and at designated timepoints up to approximately 288 hrs postdose |
| Part 1 (Itraconazole): Area Under the Curve From Time 0 to 24 Hours (AUC0-24hrs) of MK-2828 |
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Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
- Participant is in good health
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Toll Free Number | Contact | 1-888-577-8839 | Trialsites@merck.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fortea CRU Madison ( Site 0001) | Recruiting | Madison | Wisconsin | 53704 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| Itraconazole |
| Drug |
Administered orally as syrup |
|
| Midazolam | Drug | Administered orally as syrup |
|
Blood samples will be collected at multiple time points to determine the AUC0-24 of MK-2828. |
| Predose and at designated timepoints up to approximately 24 hrs postdose |
| Part 1 (Itraconazole): Time to Maximum Plasma Concentration (Tmax) of MK-2828 | Blood samples will be collected at multiple time points to determine the Tmax of MK-2828. | Predose and at designated timepoints up to approximately 288 hrs postdose |
| Part 1 (Itraconazole): Apparent Terminal Half-life (t1/2) of MK-2828 | Blood samples will be collected at multiple time points to determine the t1/2 of MK-2828. | Predose and at designated timepoints up to approximately 288 hrs postdose |
| Part 1 (Itraconazole): Apparent Clearance (CL/F) of MK-2828 | Blood samples will be collected at multiple time points to determine the CL/F of MK-2828. | Predose and at designated timepoints up to approximately 288 hrs postdose |
| Part 1 (Itraconazole): Plasma Concentration at 24 Hours (C24) of MK-2828 | Blood samples will be collected at multiple time points to determine the C24 of MK-2828. | 24 hours postdose |
| Part 1 (Itraconazole): Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-2828 | Blood samples will be collected at multiple time points to determine the Vz/F of MK-2828. | Predose and at designated timepoints up to approximately 288 hrs postdose |
| Part 1 (Itraconazole): Number of Participants Experiencing an Adverse Event (AE) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experienced an AE will be reported. | Up to approximately 28 days |
| Part 1 (Itraconazole): Number of Participants Who Discontinue Study Treatment Due to an AE | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued study treatment due to an AE will be reported. | Up to approximately 23 days |
| Part 2 (Midazolam): Area Under the Curve From Time 0 to Last Quantifiable Sample (AUC0-last) of Midazolam | Blood samples will be collected at multiple time points to determine the AUC0-last of Midazolam. | Predose and at designated timepoints up to approximately 24hrs postdose |
| Part 2 (Midazolam): Area Under the Curve From Time 0 to 24 Hours (AUC0-24hrs) of Midazolam | Blood samples will be collected at multiple time points to determine the AUC0-24 of Midazolam. | Predose and at designated timepoints up to approximately 24hrs postdose |
| Part 2 (Midazolam): Time to Maximum Plasma Concentration (Tmax) of Midazolam | Blood samples will be collected at multiple time points to determine the Tmax of Midazolam. | Predose and at designated timepoints up to approximately 24hrs postdose |
| Part 2 (Midazolam): Apparent Terminal Half-life (t1/2) of Midazolam | Blood samples will be collected at multiple time points to determine the t1/2 of Midazolam. | Predose and at designated timepoints up to approximately 24hrs postdose |
| Part 2 (Midazolam): Apparent Clearance (CL/F) of Midazolam | Blood samples will be collected at multiple time points to determine the CL/F of Midazolam. | Predose and at designated timepoints up to approximately 24hrs postdose |
| Part 2 (Midazolam): Plasma Concentration at 24 Hours (C24) of Midazolam | Blood samples will be collected at multiple time points to determine the C24 of Midazolam. | 24 hours postdose |
| Part 2 (Midazolam): Apparent Volume of Distribution During Terminal Phase (Vz/F) of Midazolam | Blood samples will be collected at multiple time points to determine the Vz/F of Midazolam. | Predose and at designated timepoints up to approximately 24hrs postdose |
| Part 2 (Midazolam): Number of Participants Experiencing an adverse event (AE) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experienced an AE will be reported. | Up to approximately 23 days |
| Part 2 (Midazolam): Number of Participants Who Discontinue Study Treatment Due to an AE | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued study treatment due to an AE will be reported. | Up to approximately 9 days |
| ID | Term |
|---|---|
| D017964 | Itraconazole |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010879 | Piperazines |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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