Healthy, Renal Impairment
Conditions
Brief summary
The goal of this study is to learn what happens to calderasib levels in a person's body over time. Researchers will measure what happens to calderasib levels in the body when it is given to people with moderate or severe renal impairment (RI) (meaning the kidneys do not work properly) as compared to people who are in good health. Researchers also want to learn about the safety of calderasib when it is given to people with RI and if people with RI can tolerate it.
Interventions
DRUGCalderasib
Oral tablet
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
The main inclusion criteria include but are not limited to the following: All participants: \- Has a BMI ≥18.0 and ≤40.0 kg/m\^2 Participants with severe or moderate RI: * With the exception of RI, is sufficiently healthy for study participation * Has stable renal function with no clinically significant change in renal status at least 29 days prior to dosing and is not currently or has not been previously on dialysis for at least 1 year Participants with normal renal function: \- Is medically healthy
Exclusion criteria
The main
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of calderasib | At designated timepoints (up to approximately 2 days postdose) | Blood samples will be collected to determine the AUC0-inf of calderasib. |
| Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of calderasib | At designated timepoints (up to approximately 2 days postdose) | Blood samples will be collected to determine the AUC0-last of calderasib. |
| Area Under the Concentration-Time Curve from Time 0 to 24 Hours (AUC0-24) of calderasib | At designated timepoints (up to 24 hours postdose) | Blood samples will be collected to determine the AUC0-24 of calderasib. |
| Plasma Concentration of calderasib at 24 Hours Postdose (C24) | At designated timepoints (up to 24 hours postdose) | Blood samples will be collected to determine the C24 of calderasib. |
| Maximum Plasma Concentration (Cmax) of calderasib | At designated timepoints (up to approximately 2 days postdose) | Blood samples will be collected to determine the Cmax of calderasib. |
| Time to Maximum Plasma Concentration (Tmax) of calderasib | At designated timepoints (up to approximately 2 days postdose) | Blood samples will be collected to determine the Tmax of calderasib. |
| Apparent Terminal Half-life (t1/2) of calderasib | At designated timepoints (up to approximately 2 days postdose) | Blood samples will be collected to determine the t1/2 of calderasib. |
| Apparent Clearance (CL/F) of calderasib | At designated timepoints (up to approximately 2 days postdose) | Blood samples will be collected to determine the CL/F of calderasib. |
| Apparent Volume of Distribution During Terminal Phase (Vz/F) of calderasib | At designated timepoints (up to approximately 2 days postdose) | Blood samples will be collected to determine the Vz/F of calderasib. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experience an Adverse Event | Up to approximately 2 weeks | An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. The number of participants who experience an adverse event will be reported. |
| Number of Participants Who Discontinue From the Study Due to an Adverse Event | Up to approximately 2 weeks | An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. The number of participants who discontinue from the study due to an adverse event will be reported. |
| Total Amount of calderasib Excreted Unchanged in Urine (Ae) | At designated timepoints (up to approximately 1 day postdose) | Urine samples will be collected to determine the Ae of calderasib. |
| Total Amount of calderasib Excreted Unchanged in Urine From 0 to 24 Hours (Ae0-24) | At designated timepoints (up to 24 hours postdose) | Urine samples will be collected to determine the Ae0-24 of calderasib. |
| Fraction of calderasib Excreted Unchanged in Urine (fe) | At designated timepoints (up to approximately 1 day postdose) | Urine samples will be collected to determine the fe of calderasib. |
| Renal Clearance (CLr) of calderasib | At designated timepoints (up to approximately 1 day postdose) | Urine samples will be collected to determine the CLr of calderasib. |
Countries
United States
Contacts
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed