A Study of MK-6552 and the Effect of Food in Healthy Participants (MK-6552-006)
NCT Number: NCT06567002
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy
Interventions: DRUG: MK-6552
Sponsor: Merck Sharp & Dohme LLC
Sex: ALL
Age: ADULT
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-09-09
Completion Date: 2024-10-31

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.

Primary Outcome Measures: Area Under the Plasma Concentration-Time Curve from Time 0 to Last Quantifiable Concentration (AUC0-last) of MK-6552 in a Fasted State, Blood samples will be collected to determine the AUC0-last of MK-6552., Predose and at designated timepoints approximately up to 3 days postdose|Area Under the Plasma Concentration-Time Curve from Time 0 to Infinity (AUC0-inf) of MK-6552 in a Fasted State, Blood samples will be collected to determine the AUC0-inf of MK-6552., Predose and at designated timepoints approximately up to 3 days postdose|Maximum Concentration (Cmax) of MK-6552 in a Fasted State, Blood samples will be collected to determine the Cmax of MK-6552., Predose and at designated timepoints approximately up to 3 days postdose|Concentration at 8 hours (C8h) of MK-6552 in a Fasted State, Blood samples will be collected to determine the C8h of MK-6552., 8 hours postdose|Concentration at 16 hours (C16h) of MK-6552 in a Fasted State, Blood samples will be collected to determine the C16h of MK-6552., 16 hours postdose|Time to maximum concentration (Tmax) of MK-6552 in a Fasted State, Blood samples will be collected to determine the Tmax of MK-6552., Predose and at designated timepoints approximately up to 3 days postdose|Apparent Terminal Half-life (t1/2) of MK-6552 in a Fasted State, Blood samples will be collected to determine the t1/2 of MK-6552., Predose and at designated timepoints approximately up to 3 days postdose
Secondary Outcome Measures: AUC0-last of MK-6552 in a Fed or Fasted State, Blood samples will be collected to determine the AUC0-last of MK-6552., Predose and at designated timepoints approximately up to 3 days postdose|AUC0-inf of MK-6552 in a Fed or Fasted State, Blood samples will be collected to determine the AUC0-inf of MK-6552., Predose and at designated timepoints approximately up to 3 days postdose|Cmax of MK-6552 in a Fed or Fasted State, Blood samples will be collected to determine the Cmax of MK-6552., Predose and at designated timepoints approximately up to 3 days postdose|C8h of MK-6552 in a Fed or Fasted State, Blood samples will be collected to determine the C8h of MK-6552., 8 hours postdose|C16h of MK-6552 in a Fed or Fasted State, Blood samples will be collected to determine the C16h of MK-6552., 16 hours postdose|Tmax of MK-6552 in a Fed or Fasted State, Blood samples will be collected to determine the Tmax of MK-6552., Predose and at designated timepoints approximately up to 3 days postdose|t1/2 of MK-6552 in a Fed or Fasted State, Blood samples will be collected to determine the t1/2 of MK-6552., Predose and at designated timepoints approximately up to 3 days postdose|Number of participants with one or more adverse events (AE), 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., Up to approximately day 35|Number of participants discontinuing from study therapy due to AE, 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., Up to approximately day 35