Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06777602 | A Clinical Study To Understand How Radiolabeled MK-5475 Is Taken Up By The Body, Broken Down And Then Removed From The Body in Healthy Participants (MK-5475-011) | PHASE1 | COMPLETED | 8 | — | — | Aug 15, 2022 | Oct 25, 2022 | Oct 29, 2025 | 1 | United States |
Amount of \[14C\]MK-5475 and its metabolites excreted in urine (Aeu) derived from urine collections at each sampling interval.
Cumulative amount of \[14C\] MK-5475 and its metabolites excreted in urine derived from urine collections at each sampling interval
Percentage of \[14C\]MK-5475 and its metabolites excreted in urine derived from urine collections at each sampling interval.
Cumulative percentage of \[14C\]MK-5475 and its metabolites excreted in urine derived from urine collections at each sampling interval.
Amount of \[14C\]MK-5475 and its metabolites excreted in feces derived from feces collections at each sampling interval.
Cumulative amount of \[14C\]MK-5475 and its metabolites excreted in feces derived from feces collections at each sampling interval.
Cumulative percentage of \[14C\]MK-5475 and its metabolites excreted in feces derived from feces collections at each sampling interval.
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.
AUC from time zero extrapolated to infinity derived from the whole blood and plasma concentration-time profiles following IV administration of \[14C\]MK-5475.
Cmax is the measure of the maximum amount of \[14C\]MK-5475 in the plasma after the dose is given.
T1/2 is the time required for \[14C\]MK-5475 concentration in the plasma to decrease by 50%.
Tmax is a measure of the time to reach the maximum concentration in the plasma after the \[14C\]MK-5475 dose.
CL is defined as apparent total clearance of \[14C\]MK-5475 from plasma after IV administration
Vz is defined as apparent volume of distribution of \[14C\]MK-5475 during terminal phase after IV administration.
AUC time zero to infinity (0-∞) of \[14C\]MK-5475 in plasma/AUC0-∞ of total radioactivity in plasma.
| Arm | Type | Description |
|---|---|---|
| [14C] MK-5475 | EXPERIMENTAL | \[14C\] MK-5475 is administered as single IV bolus dose of 100μg on Day 1. |
| Name | Type | Description |
|---|---|---|
| [14C] MK-5475 | DRUG | \[14C\] MK-5475 is administered as a single IV bolus dose in healthy male participants on Day 1. |
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 ...