Healthy
Conditions
Brief summary
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.
Interventions
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Be in good health * Has a body mass index (BMI) between 18 and 32 kg/m\^2, inclusive
Exclusion criteria
* Has an estimated glomerular filtration rate (eGFR) ≤90 mL/min/1.73 m\^2 * Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases * Has a history of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair are allowed) * Has a history of cancer (malignancy) * Is taking any medication that contains emtricitabine (FTC) or lamivudine (3TC)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Area Under the Concentration Time Curve From Time 0 to Infinity (AUC0-inf) of MK-8527 in Plasma With and Without Food | Predose and at designated timepoints (up to 336 hours postdose) | Blood samples will be collected at multiple time points to estimate AUC0-inf of MK-8527 in plasma. |
| Part 2: AUC0-inf of MK-8527 in Plasma With and Without Probenecid | Predose and at designated timepoints (up to 336 hours postdose) | Blood samples will be collected at multiple time points to estimate AUC0-inf of MK-8527 in plasma. |
| Part 3: AUC0-inf of MK-8527 in Plasma With and Without Itraconazole | Predose and at designated timepoints (up to 336 hours postdose) | Blood samples will be collected at multiple time points to estimate AUC0-inf of MK-8527 in plasma. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Predose and at designated timepoints (up to 336 hours postdose) | Blood samples will be collected at multiple time points to estimate AUC0-336 of MK-8527 in plasma. |
| Part 1: Time to Maximum Plasma Concentration (Tmax) of MK-8527 in Plasma With and Without Food | Predose and at designated timepoints (up to 336 hours postdose) | Blood samples will be collected to estimate the Tmax of MK-8527 in plasma. |
| Part 1: Maximum Plasma Concentration (Cmax) of MK-8527 in Plasma With and Without Food | Predose and at designated timepoints (up to 336 hours postdose) | Blood samples will be collected to estimate the Cmax of MK-8527 in plasma. |
| Part 1: Apparent Terminal Half-life (t1/2) of MK-8527 in Plasma With and Without Food | Predose and at designated timepoints (up to 336 hours postdose) | Blood samples will be collected to estimate the apparent terminal t1/2 of MK-8527 in plasma. |
| Part 1: Number of Participants Who Experience an Adverse Event (AE) | Up to approximately 43 days | 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. |
| Part 1: Number of Participants Who Discontinue Study Treatment Due to an AE | Up to approximately 43 days | 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. |
| Part 2: AUC0-336 of MK-8527 in Plasma With and Without Probenecid | Predose and at designated timepoints (up to 336 hours postdose) | Blood samples will be collected to estimate the AUC0-336 of MK-8527 in plasma. |
| Part 2: Tmax of MK-8527 in Plasma with and without Probenecid | Predose and at designated timepoints (up to 336 hours postdose) | Blood samples will be collected to estimate the Tmax of MK-8527 in plasma. |
| Part 2: Cmax of MK-8527 in Plasma With and Without Probenecid | Predose and at designated timepoints (up to 336 hours postdose) | Blood samples will be collected to estimate the Cmax of MK-8527 in plasma. |
| Part 2: Apparent Terminal t1/2 of MK-8527 in Plasma With and Without Probenecid | Predose and at designated timepoints (up to 336 hours postdose) | Blood samples will be collected to estimate the apparent terminal t1/2 of MK-8527 in plasma. |
| Part 2: Urine Concentration at 72 Hours of MK-8527 | At designated timepoints (up to 72 hours postdose) | Urine samples will be collected to estimate the urine concentration of MK-8527. |
| Part 2: Renal Clearance of MK-8527 | At designated timepoints (up to 72 hours postdose) | Urine samples will be collected to estimate the renal clearance of MK-8527. |
| Part 2: Number of Participants Who Experience an AE | Up to approximately 43 days | 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. |
| Part 2: Number of Participants Who Discontinue Study Treatment Due to an AE | Up to approximately 43 days | 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. |
| Part 3: AUC0-336 of MK-8527 in Plasma With and Without Itraconazole | Predose and at designated timepoints (up to 336 hours postdose) | Blood samples will be collected at multiple time points to estimate AUC0-336 of MK-8527 in plasma. |
| Part 3: Tmax of MK-8527 in Plasma With and Without Itraconazole | Predose and at designated timepoints (up to 336 hours postdose) | Blood samples will be collected to estimate the Tmax of MK-8527 in plasma. |
| Part 3: Cmax of MK-8527 in Plasma With and Without Itraconazole | Predose and at designated timepoints (up to 336 hours postdose) | Blood samples will be collected to estimate the Cmax of MK-8527 in plasma. |
| Part 3: Apparent Terminal t1/2 of MK-8527 in Plasma With and Without Itraconazole | Predose and at designated timepoints (up to 336 hours postdose) | Blood samples will be collected to estimate the apparent t1/2 of MK-8527 in plasma. |
| Part 3: Urine Concentration at 72 Hours of MK-8527 | At designated timepoints (up to 72 hours postdose) | Urine samples will be collected to estimate the urine concentration of MK-8527. |
| Part 3: Renal Clearance of MK-8527 | At designated timepoints (up to 72 hours postdose) | Urine samples will be collected to estimate the renal clearance of MK-8527. |
| Part 3: Number of Participants Who Experience an AE | Up to approximately 43 days | 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. |
| Part 3: Number of Participants Who Discontinue Study Treatment Due to an AE | Up to approximately 43 days | 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. |
Countries
United States
Contacts
CONTACTToll Free Number
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed