Floridian Clinical Research, LLC ( Site 0001)
Miami Lakes, Florida, 33016, United States
Location status: Recruiting
NCT Number: NCT07734610
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Phase 1
Miami Lakes, Florida, 33016, United States
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
The main inclusion criteria include but are not limited to the following:
All participants:
Participants with Severe Renal impairment (RI):
Healthy volunteers:
Exclusion criteria
The main exclusion criteria include but are not limited to the following:
Renal Impairment Participants:
Healthy Matched Control Participants:
Oral administration
Other names: MK-1026
Time frame: At designated timepoints up to approximately 336 hours postdose
Blood samples will be collected to determine the AUC0-inf of Nemtabrutinib in plasma.
Time frame: At designated timepoints up to approximately 336 hours postdose
Blood samples will be collected to determine the AUC0-last of Nemtabrutinib in plasma.
Time frame: Up to approximately 24 hours postdose
Blood samples will be collected to determine the AUC0-24 of Nemtabrutinib.
Time frame: At designated timepoints up to approximately 336 hours postdose
Blood samples will be collected to determine the (Cmax) of Nemtabrutinib.
Time frame: Up to approximately 24 hours postdose
Blood samples will be collected to determine the C24 of Nemtabrutinib.
Time frame: At designated timepoints up to approximately 336 hours postdose
Blood samples will be collected to determine the (Tmax) of Nemtabrutinib.
Time frame: At designated timepoints up to approximately 336 hours postdose
Blood samples will be collected to determine the (t1/2) of Nemtabrutinib.
Time frame: At designated timepoints up to approximately 336 hours postdose
Blood samples will be collected to determine the CL/F of Nemtabrutinib.
Time frame: At designated timepoints up to approximately 336 hours postdose
Blood samples will be collected to determine the Vz/F of Nemtabrutinib.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Merck Sharp & Dohme LLC
Industry
An Open-Label, Single-Dose Clinical Study to Evaluate the Pharmacokinetics of Nemtabrutinib in Participants With Severe Renal Impairment
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04119843
Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications
Scottsdale, Arizona, United States
View Trial DetailsNCT03165071
Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications
Pilsen, Czechia
View Trial DetailsNCT02207088
Blood-Borne Infections, Chronic Disease
View Trial DetailsNCT01043094
Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications
Minneapolis, Minnesota, United States
View Trial Details