Healthy, Severe Renal Impairment
Conditions
Brief summary
The purpose of this study is to learn what happens to nemtabrutinib in a person's body when given to participants with severe kidney disease and to healthy participants.
Interventions
DRUGNemtabrutinib
Oral administration
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
The main inclusion criteria include but are not limited to the following: All participants: * Has a body mass index (BMI) ≥18.0 and ≤40.0 kg/m\^2 Participants with Severe Renal impairment (RI): * The participant has stable renal function as determined by historical measurements. Healthy volunteers: * Is medically healthy with no clinically significant medical history
Exclusion criteria
The main
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration Time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Nemtabrutinib in Plasma | At designated timepoints up to approximately 336 hours postdose | Blood samples will be collected to determine the AUC0-inf of Nemtabrutinib in plasma. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration Versus Time Curve from 0 to the Time of the Last Quantifiable Sample (AUC0-last) of Nemtabrutinib | At designated timepoints up to approximately 336 hours postdose | Blood samples will be collected to determine the AUC0-last of Nemtabrutinib in plasma. |
| Area Under the Concentration Versus Time Curve from 0 to 24 Hours Postdose (AUC0-24) of Nemtabrutinib | Up to approximately 24 hours postdose | Blood samples will be collected to determine the AUC0-24 of Nemtabrutinib. |
| Maximum Plasma Concentration (Cmax) of Nemtabrutinib in Plasma | At designated timepoints up to approximately 336 hours postdose | Blood samples will be collected to determine the (Cmax) of Nemtabrutinib. |
| Concentration at 24 Hours Postdose (C24) of Nemtabrutinib in Plasma | Up to approximately 24 hours postdose | Blood samples will be collected to determine the C24 of Nemtabrutinib. |
| Time of the Maximum Observed Concentration (Tmax) of Nemtabrutinib in Plasma | At designated timepoints up to approximately 336 hours postdose | Blood samples will be collected to determine the (Tmax) of Nemtabrutinib. |
| Time of the Maximum Observed Concentration (t1/2) of Nemtabrutinib in Plasma | At designated timepoints up to approximately 336 hours postdose | Blood samples will be collected to determine the (t1/2) of Nemtabrutinib. |
| Apparent Total Plasma Clearance (CL/F) of Nemtabrutinib | At designated timepoints up to approximately 336 hours postdose | Blood samples will be collected to determine the CL/F of Nemtabrutinib. |
| Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) of Nemtabrutinib in Plasma | At designated timepoints up to approximately 336 hours postdose | Blood samples will be collected to determine the Vz/F of Nemtabrutinib. |
| Number of Participants Who Experience an Adverse Event (AE) | Up to approximately 15 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. |
| Number of Participants Who Discontinue From the Study Due to an AE | Up to approximately 15 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 from the study due to an AE will be reported. |
Countries
United States
Contacts
CONTACTToll Free Number
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed