Clinical trial NCT06567002: A Study of MK-6552 and the Effect of Food in Healthy Participants (MK-6552-006)
Official title: A Study to Evaluate the Pharmacokinetics of Single Dose Formulations of MK-6552 and the Effect of Food in Healthy Study Participants
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-08-22
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: Area Under the Plasma Concentration-Time Curve from Time 0 to Last Quantifiable Concentration (AUC0-last) of MK-6552 in a Fasted State
timeFrame: Predose and at designated timepoints approximately up to 3 days postdose
measure: Area Under the Plasma Concentration-Time Curve from Time 0 to Infinity (AUC0-inf) of MK-6552 in a Fasted State
timeFrame: Predose and at designated timepoints approximately up to 3 days postdose
measure: Maximum Concentration (Cmax) of MK-6552 in a Fasted State
timeFrame: Predose and at designated timepoints approximately up to 3 days postdose
measure: Concentration at 8 hours (C8h) of MK-6552 in a Fasted State
timeFrame: 8 hours postdose
measure: Concentration at 16 hours (C16h) of MK-6552 in a Fasted State
timeFrame: 16 hours postdose
measure: Time to maximum concentration (Tmax) of MK-6552 in a Fasted State
timeFrame: Predose and at designated timepoints approximately up to 3 days postdose
measure: Apparent Terminal Half-life (t1/2) of MK-6552 in a Fasted State
timeFrame: Predose and at designated timepoints approximately up to 3 days postdose
Secondary outcomes:
measure: AUC0-last of MK-6552 in a Fed or Fasted State
timeFrame: Predose and at designated timepoints approximately up to 3 days postdose
measure: AUC0-inf of MK-6552 in a Fed or Fasted State
timeFrame: Predose and at designated timepoints approximately up to 3 days postdose
measure: Cmax of MK-6552 in a Fed or Fasted State
timeFrame: Predose and at designated timepoints approximately up to 3 days postdose
measure: C8h of MK-6552 in a Fed or Fasted State
timeFrame: 8 hours postdose
measure: C16h of MK-6552 in a Fed or Fasted State
timeFrame: 16 hours postdose
measure: Tmax of MK-6552 in a Fed or Fasted State
timeFrame: Predose and at designated timepoints approximately up to 3 days postdose
measure: t1/2 of MK-6552 in a Fed or Fasted State
timeFrame: Predose and at designated timepoints approximately up to 3 days postdose
measure: Number of participants with one or more adverse events (AE)
timeFrame: Up to approximately day 35
measure: Number of participants discontinuing from study therapy due to AE
timeFrame: Up to approximately day 35
Other outcomes:
Locations:
city: South Miami
country: United States
facility: QPS-MRA, LLC-Early Phase ( Site 0001)
state: Florida
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: