Healthy
Conditions
Brief summary
The purpose of this study is to learn what happens to calderasib in a healthy person's body over time and how it is cleared from the body.
Interventions
DRUG[14C]Calderasib
Oral administration
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 55 Years
Healthy volunteers
Yes
Inclusion criteria
Key inclusion criteria include but are not limited to the following: * Is in good health based on medical history, physical examination,vital signs measurements, and electrocardiogram (ECG)s performed before randomization. * Has a body mass index (BMI) 18 to 32 kg/m2, inclusive, at screening
Exclusion criteria
The key
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of plasma Calderasib | Predose and at designated timepoints up to Day 15 | Bood samples will be collected to determine the AUC0-inf of calderasib in plasma. |
| Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of plasma Calderasib | Predose and at designated timepoints up to Day 15 | Blood samples will be collected to determine the AUC0-last of calderasib in plasma. |
| Area Under the Concentration-Time Curve from 0 to 24 hours (AUC0-24) of plasma Calderasib | Predose and at designated timepoints up to Day 15 | Blood samples will be collected to determine the AUC0-24 of plasma calderasib in plasma. |
| Maximum Concentration (Cmax) of plasma Calderasib | Predose and at designated timepoints up to Day 15 | Blood samples will be collected to determine the Cmax of calderasib in plasma. |
| Concentration at 24 hours postdose (C24) of plasma Calderasib | Predose and at designated timepoints up to Day 15 | Blood samples will be collected to determine the C24 of calderasib in plasma. |
| Time to Reach Maximum Concentration (Tmax) of plasma Calderasib | Predose and at designated timepoints up to Day 15 | Blood samples will be collected to determine the Tmax of calderasib in plasma. |
| Apparent Half Life (t½) of plasma Calderasib | Predose and at designated timepoints up to Day 15 | Blood samples will be collected to determine the t1/2 of calderasib in plasma. |
| Apparent Total Clearance (CL/F) of plasma Calderasib | Predose and at designated timepoints up to Day 15 | Blood samples will be collected to determine the CL/F of calderasib in plasma. |
| Apparent Volume of Distribution during the Terminal Elimination Phase (Vz/F) of plasma Calderasib | Predose and at designated timepoints up to Day 15 | Blood samples will be collected to determine the Vz/F of calderasib in plasma. |
| AUC0-inf/Total Radioactivity Ratio of plasma Calderasib | Predose and at designated timepoints up to Day 15 | Blood samples will be collected to determine the AUC0-inf/Total Radioactivity Ratio of calderasib in plasma. |
| Amount Excreted in the Urine (Aeu) of Calderasib | Predose and at designated timepoints up to Day 15 | Urine samples will be collected to determine the Aeu of calderasib |
| Cumulative Aeu of Calderasib | Predose and at designated timepoints up to Day 15 | Urine samples will be collected to determine the cumulative Ae of calderasib. |
| Percentage Excreted in the Urine (feu) of Calderasib | Predose and at designated timepoints up to Day 15 | Urine samples will be collected to determine the feu of calderasib. |
| Cumulative feu of Calderasib | Predose and at designated timepoints up to Day 15 | Urine samples will be collected to determine the cumulative feu of calderasib. |
| Amount Excreted in the Feces (Aef) of Calderasib | Predose and at designated timepoints up to Day 15 | Feces samples will be collected to determine the Aef of calderasib. |
| Cumulative Aef of Calderasib | Predose and at designated timepoints up to Day 15 | Feces samples will be collected to determine the cumulative Aef of calderasib. |
| Percentage Excreted in the Feces (fef) of Calderasib | Predose and at designated timepoints up to Day 15 | Feces samples will be collected to determine the fef of calderasib. |
| Cumulative fef of Calderasib | Predose and at designated timepoints up to Day 15 | Feces samples will be collected to determine the cumulative fef of calderasib. |
| Metabolites in Plasma of Calderasib | Predose and at designated timepoints up to Day 15 | Blood samples will be collected to determine the metabolites of calderasib. |
| Metabolites in Urine of Calderasib | Predose and at designated timepoints up to Day 15 | Urine samples will be collected to determine the metabolites of calderasib. |
| Metabolites in Feces of Calderasib | Predose and at designated timepoints up to Day 15 | Feces samples will be collected to determine the metabolites of calderasib. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing an Adverse Event (AE) | Up to ~ 28 days | An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study treatment. For each arm, the number of participants experiencing an AE will be assessed. |
| Number of Participants Discontinuing Study Treatment due to an AE | Up to ~ 28 days | An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study treatment. For each arm, the number of participants experiencing an AE will be assessed. |
Countries
United States
Outcome results
None listed