Healthy
Conditions
Brief summary
The goal of this study is to understand how radiolabeled MK-5475 administered intravenously (IV) is taken up by the body, broken down and then removed from the body in healthy male participants. The study also aims to understand how much of the compound is broken down and how much leaves the body unchanged.
Interventions
DRUG[14C] MK-5475
\[14C\] MK-5475 is administered as a single IV bolus dose in healthy male participants on Day 1.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Is in good health. * Body mass index (BMI) \>18 and ≤32 kg/m2, inclusive.
Exclusion criteria
* Has history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases. * Has significant multiple and/or severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs or food. * Has had a major surgery and/or donated or lost 1 unit of blood (approximately 500 mL) or blood products within 4 weeks prior to the prestudy (screening). * Has history of exposure to significant diagnostic or therapeutic radiation or current employment in a job requiring radiation exposure monitoring within 12 months prior to check-in. * Has participated in more than 3 radiolabeled drug studies in the last 12 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC0-infinity Plasma [14C]MK-5475/Total Radioactivity Ratio | At designated time points (Up to ~ 23 days) | AUC time zero to infinity (0-∞) of \[14C\]MK-5475 in plasma/AUC0-∞ of total radioactivity in plasma. |
| Apparent Total Clearance (CL; MK-5475 only) | At designated time points (Up to ~ 23 days) | CL is defined as apparent total clearance of \[14C\]MK-5475 from plasma after IV administration |
| Apparent Volume of Distribution (Vz; MK-5475 only) | At designated time points (Up to ~ 23 days) | Vz is defined as apparent volume of distribution of \[14C\]MK-5475 during terminal phase after IV administration. |
| Amount Excreted in Urine (Aeu) | At designated time points (Up to ~ 23 days) | Amount of \[14C\]MK-5475 and its metabolites excreted in urine (Aeu) derived from urine collections at each sampling interval. |
| Cumulative Aeu | At designated time points (Up to ~ 23 days) | Cumulative amount of \[14C\] MK-5475 and its metabolites excreted in urine derived from urine collections at each sampling interval |
| Percentage Excreted in Urine (feu) | At designated time points (Up to ~ 23 days) | Percentage of \[14C\]MK-5475 and its metabolites excreted in urine derived from urine collections at each sampling interval. |
| Cumulative feu | At designated time points (Up to ~ 23 days) | Cumulative percentage of \[14C\]MK-5475 and its metabolites excreted in urine derived from urine collections at each sampling interval. |
| Amount Excreted in Feces (Aef) | At designated time points (Up to ~ 23 days) | Amount of \[14C\]MK-5475 and its metabolites excreted in feces derived from feces collections at each sampling interval. |
| Cumulative Aef | At designated time points (Up to ~ 23 days) | Cumulative amount of \[14C\]MK-5475 and its metabolites excreted in feces derived from feces collections at each sampling interval. |
| Cumulative Fef | At designated time points (Up to ~ 23 days) | Cumulative percentage of \[14C\]MK-5475 and its metabolites excreted in feces derived from feces collections at each sampling interval. |
| AUC0-t | At designated time points (Up to ~ 23 days) | Area under concentration time curve (AUC) from time zero to the last quantifiable concentration derived from the whole blood and plasma concentration-time profiles following IV administration of \[14C\]MK-5475. |
| AUC0-infinity | At designated time points (Up to ~ 23 days) | AUC from time zero extrapolated to infinity derived from the whole blood and plasma concentration-time profiles following IV administration of \[14C\]MK-5475. |
| Maximum Plasma Concentration (Cmax) | At designated time points (Up to ~ 23 days) | Cmax is the measure of the maximum amount of \[14C\]MK-5475 in the plasma after the dose is given. |
| Half-life t1/2 | At designated time points (Up to ~ 23 days) | T1/2 is the time required for \[14C\]MK-5475 concentration in the plasma to decrease by 50%. |
| Time to Maximum Plasma Concentration (Tmax), | At designated time points (Up to ~ 23 days) | Tmax is a measure of the time to reach the maximum concentration in the plasma after the \[14C\]MK-5475 dose. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Discontinue Study Due to an AE | Up to ~ 30 days | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of 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 (AE) | Up to ~ 30 days | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of 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