Healthy
Conditions
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.
Interventions
BIOLOGICALMK-6194
single injected dose
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 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Outcome results
None listed