MK-6194 Site of Injection Study in Healthy Adult Participants (MK-6194-013)
- Registration Number
- NCT06649877
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Abdomen Injection MK-6194 Participants will receive a single dose of MK-6194 injected into the abdomen. Thigh Injection MK-6194 Participants will receive a single dose of MK-6194 injected into the thigh.
- Primary Outcome Measures
Name Time Method Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of MK-6194 At designated timepoints (up to approximately 4 weeks postdose) Blood samples will be collected to determine the AUC0-Last of MK-6194.
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-6194 At designated timepoints (up to approximately 4 weeks postdose) Blood samples will be collected to determine the AUC0-Inf of MK-6194.
Maximum Plasma Concentration (Cmax) of MK-6194 At designated timepoints (up to approximately 4 weeks postdose) Blood samples will be collected to determine the Cmax of MK-6194.
Time to Maximum Plasma Concentration (Tmax) of MK-6194 At designated timepoints (up to approximately 4 weeks postdose) Blood samples will be collected to determine the Tmax of MK-6194.
Apparent Clearance (CL/F) of MK-6194 At designated timepoints (up to approximately 4 weeks postdose) Blood samples will be collected to determine the CL/F of MK-6194.
Apparent Terminal Half-life (t1/2) of MK-6194 At designated timepoints (up to approximately 4 weeks postdose) Blood samples will be collected to determine the t1/2 of MK-6194.
Apparent Volume of Distribution (Vz/F) of MK-6194 At designated timepoints (up to approximately 4 weeks postdose) Blood samples will be collected to determine the Vz/F of MK-6194.
- Secondary Outcome Measures
Name Time Method Number of Participants Who Experience an Adverse Event Up to approximately 12 weeks An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.
Number of Participants Who Discontinue Study Due to an AE Up to approximately 12 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study due to an AE will be reported.
Trial Locations
- Locations (1)
QPS-MRA, LLC-Early Phase (Site 0001)
🇺🇸South Miami, Florida, United States