Healthy
Conditions
Brief summary
The primary purpose of this study is to learn what happens to levels of MK-6552 in the blood when MK-6552 is given in different forms to healthy adult participants under fasted and fed conditions.
Interventions
DRUGMK-6552
Oral Administration
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
The main inclusion criteria include but are not limited to the following: * Be in good health The main
Exclusion criteria
include but are not limited to the following: * 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 * History of cancer (malignancy) * Has received any vaccine starting from 30 days prior to study intervention or is scheduled to receive any vaccine through 30 days following study intervention
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Plasma Concentration-Time Curve from Time 0 to Last Quantifiable Concentration (AUC0-last) of MK-6552 in a Fasted State | Predose and at designated timepoints approximately up to 3 days postdose | Blood samples will be collected to determine the AUC0-last of MK-6552. |
| Area Under the Plasma Concentration-Time Curve from Time 0 to Infinity (AUC0-inf) of MK-6552 in a Fasted State | Predose and at designated timepoints approximately up to 3 days postdose | Blood samples will be collected to determine the AUC0-inf of MK-6552. |
| Maximum Concentration (Cmax) of MK-6552 in a Fasted State | Predose and at designated timepoints approximately up to 3 days postdose | Blood samples will be collected to determine the Cmax of MK-6552. |
| Concentration at 8 hours (C8h) of MK-6552 in a Fasted State | 8 hours postdose | Blood samples will be collected to determine the C8h of MK-6552. |
| Concentration at 16 hours (C16h) of MK-6552 in a Fasted State | 16 hours postdose | Blood samples will be collected to determine the C16h of MK-6552. |
| Time to maximum concentration (Tmax) of MK-6552 in a Fasted State | Predose and at designated timepoints approximately up to 3 days postdose | Blood samples will be collected to determine the Tmax of MK-6552. |
| Apparent Terminal Half-life (t1/2) of MK-6552 in a Fasted State | Predose and at designated timepoints approximately up to 3 days postdose | Blood samples will be collected to determine the t1/2 of MK-6552. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with one or more adverse events (AE) | Up to approximately day 35 | An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The number of participants who experience an AE will be reported. |
| AUC0-last of MK-6552 in a Fed or Fasted State | Predose and at designated timepoints approximately up to 3 days postdose | Blood samples will be collected to determine the AUC0-last of MK-6552. |
| Number of participants discontinuing from study therapy due to AE | Up to approximately day 35 | An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The number of participants who discontinue study treatment due to an AE will be reported. |
| AUC0-inf of MK-6552 in a Fed or Fasted State | Predose and at designated timepoints approximately up to 3 days postdose | Blood samples will be collected to determine the AUC0-inf of MK-6552. |
| Cmax of MK-6552 in a Fed or Fasted State | Predose and at designated timepoints approximately up to 3 days postdose | Blood samples will be collected to determine the Cmax of MK-6552. |
| C8h of MK-6552 in a Fed or Fasted State | 8 hours postdose | Blood samples will be collected to determine the C8h of MK-6552. |
| C16h of MK-6552 in a Fed or Fasted State | 16 hours postdose | Blood samples will be collected to determine the C16h of MK-6552. |
| Tmax of MK-6552 in a Fed or Fasted State | Predose and at designated timepoints approximately up to 3 days postdose | Blood samples will be collected to determine the Tmax of MK-6552. |
| t1/2 of MK-6552 in a Fed or Fasted State | Predose and at designated timepoints approximately up to 3 days postdose | Blood samples will be collected to determine the t1/2 of MK-6552. |
Countries
United States
Outcome results
None listed