A Phase 1 interventional study of Calderasib in Healthy and Hepatic Impairment, sponsored by Merck Sharp & Dohme LLC. Completed at 3 sites in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-04.
Sponsored by Merck Sharp & Dohme LLC · Phase 1, Interventional, and Basic science
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.
Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
All participants will receive a single oral dose of calderasib on Day 1.
Drug: Calderasib
Oral Tablet
Also known as: MK-1084
Area Under the Concentration Versus Time Curve from 0 to the Time of the Last Quantifiable Sample (AUC0-last) of Calderasib
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
Area Under the Concentration Versus Time Curve from 0 to Infinity (AUC0-inf) of Calderasib
Blood samples will be collected to determine the AUC0-inf of calderasib in plasma.
Time frame: At designated timepoints up to approximately 7 days post-dose
Area Under the Concentration Versus Time Curve from 0 to 24 hours post-dose (AUC0-24) of Calderasib
Blood samples will be collected to determine the AUC0-24 of calderasib in plasma.
Time frame: Up to approximately 24 hours post-dose
Maximum Observed Drug Concentration (Cmax) of Calderasib
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
Time to Maximum Observed Drug Concentration (Tmax) of Calderasib
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
Apparent Terminal Half-life (t1/2) of Calderasib
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
Apparent Clearance (CL/F) of Calderasib
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
Apparent Volume of Distribution During Terminal Phase (Vz/F) of Calderasib
Blood samples will be collected to determine the Vz/F of calderasib in plasma.
Time frame: At designated timepoints up to approximately 7 days post-dose
Number of Participants Who Experience an Adverse Event (AE)
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
Number of Participants Who Discontinue Study Due to an AE
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.
Time frame: Up to approximately 14 days
Plan to share: Yes — https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Merck Sharp & Dohme LLC