Healthy
Conditions
Brief summary
The main goals of this study are: * To learn what happens to one dose of MK-2828 in a healthy person's body over time when it is taken with itraconzole * To learn what happens to one dose of midazolam in a healthy person's body over time when it is taken with MK-2828 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.
Interventions
DRUGMK-2828
Administered orally as capsule
DRUGItraconazole
Administered orally as syrup
DRUGMidazolam
Administered orally as syrup
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
24 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
The main inclusion criteria include but are not limited to the following: \- Participant is in good health
Exclusion criteria
The main
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1 (Itraconazole): Maximum Plasma Concentration (Cmax) of MK-2828 | Predose and at designated timepoints up to approximately 288 hrs postdose | Blood samples will be collected at multiple time points to determine the Cmax of MK-2828. |
| Part 2 (Midazolam): Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Midazolam | Predose and at designated timepoints up to approximately 24hrs postdose | Blood samples will be collected at multiple time points to determine the AUC0-inf of Midazolam. |
| Part 2 (Midazolam): Maximum Plasma Concentration (Cmax) of Midazolam | Predose and at designated timepoints up to approximately 24hrs postdose | Blood samples will be collected at multiple time points to determine the Cmax of Midazolam. |
| Part 1 (Itraconazole): Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of MK-2828 | Predose and at designated timepoints up to approximately 288 hours (hrs) postdose | Blood samples will be collected at multiple time points to determine the AUC0-inf of MK-2828. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part 1 (Itraconazole): Apparent Terminal Half-life (t1/2) of MK-2828 | Predose and at designated timepoints up to approximately 288 hrs postdose | Blood samples will be collected at multiple time points to determine the t1/2 of MK-2828. |
| Part 1 (Itraconazole): Apparent Clearance (CL/F) of MK-2828 | Predose and at designated timepoints up to approximately 288 hrs postdose | Blood samples will be collected at multiple time points to determine the CL/F of MK-2828. |
| Part 1 (Itraconazole): Plasma Concentration at 24 Hours (C24) of MK-2828 | 24 hours postdose | Blood samples will be collected at multiple time points to determine the C24 of MK-2828. |
| Part 1 (Itraconazole): Number of Participants Experiencing an Adverse Event (AE) | Up to approximately 28 days | 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. |
| Part 1 (Itraconazole): Number of Participants Who Discontinue Study Treatment Due to an AE | Up to approximately 23 days | 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. |
| Part 2 (Midazolam): Area Under the Curve From Time 0 to Last Quantifiable Sample (AUC0-last) of Midazolam | Predose and at designated timepoints up to approximately 24hrs postdose | Blood samples will be collected at multiple time points to determine the AUC0-last of Midazolam. |
| Part 2 (Midazolam): Area Under the Curve From Time 0 to 24 Hours (AUC0-24hrs) of Midazolam | Predose and at designated timepoints up to approximately 24hrs postdose | Blood samples will be collected at multiple time points to determine the AUC0-24 of Midazolam. |
| Part 2 (Midazolam): Time to Maximum Plasma Concentration (Tmax) of Midazolam | Predose and at designated timepoints up to approximately 24hrs postdose | Blood samples will be collected at multiple time points to determine the Tmax of Midazolam. |
| Part 2 (Midazolam): Apparent Terminal Half-life (t1/2) of Midazolam | Predose and at designated timepoints up to approximately 24hrs postdose | Blood samples will be collected at multiple time points to determine the t1/2 of Midazolam. |
| Part 2 (Midazolam): Apparent Clearance (CL/F) of Midazolam | Predose and at designated timepoints up to approximately 24hrs postdose | Blood samples will be collected at multiple time points to determine the CL/F of Midazolam. |
| Part 2 (Midazolam): Plasma Concentration at 24 Hours (C24) of Midazolam | 24 hours postdose | Blood samples will be collected at multiple time points to determine the C24 of Midazolam. |
| Part 2 (Midazolam): Apparent Volume of Distribution During Terminal Phase (Vz/F) of Midazolam | Predose and at designated timepoints up to approximately 24hrs postdose | Blood samples will be collected at multiple time points to determine the Vz/F of Midazolam. |
| Part 2 (Midazolam): Number of Participants Experiencing an adverse event (AE) | Up to approximately 23 days | 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. |
| Part 1 (Itraconazole): Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-2828 | Predose and at designated timepoints up to approximately 288 hrs postdose | Blood samples will be collected at multiple time points to determine the Vz/F of MK-2828. |
| Part 2 (Midazolam): Number of Participants Who Discontinue Study Treatment Due to an AE | Up to approximately 9 days | 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. |
| Part 1 (Itraconazole): Area Under the Curve From Time 0 to Last Quantifiable Sample (AUC0-last) of MK-2828 | Predose and at designated timepoints up to approximately 288 hrs postdose | Blood samples will be collected at multiple time points to determine the AUC0-last of MK-2828. |
| Part 1 (Itraconazole): Area Under the Curve From Time 0 to 24 Hours (AUC0-24hrs) of MK-2828 | Predose and at designated timepoints up to approximately 24 hrs postdose | Blood samples will be collected at multiple time points to determine the AUC0-24 of MK-2828. |
| Part 1 (Itraconazole): Time to Maximum Plasma Concentration (Tmax) of MK-2828 | Predose and at designated timepoints up to approximately 288 hrs postdose | Blood samples will be collected at multiple time points to determine the Tmax of MK-2828. |
Countries
United States
Contacts
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed