Clinical trial NCT06649877: MK-6194 Site of Injection Study in Healthy Adult Participants (MK-6194-013)
Official title: A Randomized Clinical Study to Evaluate the Impact of Injection Site (Thigh vs Abdomen) on the Pharmacokinetics and Relative Bioavailability of Subcutaneously Injected MK-6194 in Healthy Adult Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-10-21
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this study is to learn what happens to MK-6194 in a healthy person's body when different injection sites are used. Researchers will compare what happens to MK-6194 in a healthy person's body when it is injected into the abdomen and when it is injected into the thigh. Researchers think that the average amount of MK-6194 in a person's body over time will be similar when injected into the thigh or abdomen. They also want to learn if it is safe to inject MK-6194 into the abdomen and thigh, and if people tolerate it.


Eligibility criteria: Inclusion Criteria:

The key inclusion criteria include but are not limited to the following:

* Is in good health
* Has a body mass index (BMI) within 18 to 35 kg/m2 and weighs at least 50 kg

Exclusion Criteria:

The key exclusion criteria include but are not limited to the following:

* 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 cancer

Primary outcomes:
measure: Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of MK-6194
timeFrame: At designated timepoints (up to approximately 4 weeks postdose)
measure: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-6194
timeFrame: At designated timepoints (up to approximately 4 weeks postdose)
measure: Maximum Plasma Concentration (Cmax) of MK-6194
timeFrame: At designated timepoints (up to approximately 4 weeks postdose)
measure: Time to Maximum Plasma Concentration (Tmax) of MK-6194
timeFrame: At designated timepoints (up to approximately 4 weeks postdose)
measure: Apparent Clearance (CL/F) of MK-6194
timeFrame: At designated timepoints (up to approximately 4 weeks postdose)
measure: Apparent Terminal Half-life (t1/2) of MK-6194
timeFrame: At designated timepoints (up to approximately 4 weeks postdose)
measure: Apparent Volume of Distribution (Vz/F) of MK-6194
timeFrame: At designated timepoints (up to approximately 4 weeks postdose)
Secondary outcomes:
measure: Number of Participants Who Experience an Adverse Event
timeFrame: Up to approximately 12 weeks
measure: Number of Participants Who Discontinue Study Due to an AE
timeFrame: Up to approximately 12 weeks
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: