Calderasib
DrugOral Tablet
Other names: MK-1084
NCT Number: NCT07219550
The purpose 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 participants with hepatic (liver) impairment and healthy participants. Researchers also want to learn about the safety of MK-1084 when it is given to people with hepatic impairment and if people with hepatic impairment can tolerate it.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Phase 1
Arizona Clinical Trials ( Site 0003), Chandler, Arizona, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
The main inclusion criteria include but are not limited to:
All participants:
Participants with hepatic impairment (HI):
Healthy volunteers:
The main exclusion criteria include but are not limited to:
All participants:
Participants with HI:
Healthy volunteers:
Oral Tablet
Other names: MK-1084
Time frame: At designated timepoints up to approximately 7 days post-dose
Blood samples will be collected to determine the AUC0-last of calderasib in plasma.
Time frame: At designated timepoints up to approximately 7 days post-dose
Blood samples will be collected to determine the AUC0-inf of calderasib in plasma.
Time frame: Up to approximately 24 hours post-dose
Blood samples will be collected to determine the AUC0-24 of calderasib in plasma.
Time frame: At designated timepoints up to approximately 7 days post-dose
Blood samples will be collected to determine the Cmax of calderasib in plasma.
Time frame: At designated timepoints up to approximately 7 days post-dose
Blood samples will be collected to determine the Tmax of calderasib in plasma.
Time frame: At designated timepoints up to approximately 7 days post-dose
Blood samples will be collected to determine the t1/2 of calderasib in plasma.
Time frame: At designated timepoints up to approximately 7 days post-dose
Blood samples will be collected to determine the CL/F of calderasib in plasma.
Time frame: At designated timepoints up to approximately 7 days post-dose
Blood samples will be collected to determine the Vz/F of calderasib in plasma.
Time frame: Up to approximately 14 days
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. The number of participants experiencing AEs will be reported.
Time frame: Up to approximately 14 days
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. The number of participants discontinuing the study due to AEs will be reported.
Contact information is provided by the study sponsor or research team.
Merck Sharp & Dohme LLC
Industry
A Clinical Study to Evaluate the Effect of Hepatic Impairment on the Single-Dose Pharmacokinetics of MK-1084
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.
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