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Clinical Trial NCT07219550 for Healthy, Hepatic Impairment is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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A Study of Calderasib (MK-1084) in Participants With Hepatic Impairment and Healthy Volunteers (MK-1084-017) Phase 1 58
Clinical Trial NCT07219550 is designed to study Basic Science for Healthy, Hepatic Impairment. It is a Phase 1 interventional study that is recruiting, having started on November 5, 2025, with plans to enroll 58 participants. Led by Merck Sharp & Dohme LLC, it is expected to complete by August 14, 2026. The latest data from ClinicalTrials.gov was last updated on March 5, 2026.
Brief Summary
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 tole...Show More
Official Title
A Clinical Study to Evaluate the Effect of Hepatic Impairment on the Single-Dose Pharmacokinetics of MK-1084
Conditions
HealthyHepatic ImpairmentOther Study IDs
- 1084-017
- MK-1084-017 (Other Identifier) (MSD)
NCT ID Number
Start Date (Actual)
2025-11-05
Last Update Posted
2026-03-05
Completion Date (Estimated)
2026-08-14
Enrollment (Estimated)
58
Study Type
Interventional
PHASE
Phase 1
Status
Recruiting
Primary Purpose
Basic Science
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalCalderasib All participants will receive a single oral dose of calderasib on Day 1. | Calderasib Oral Tablet |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | At designated timepoints up to approximately 7 days post-dose |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | 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. | Up to approximately 14 days |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
All participants:
- Has a body mass index (BMI) between 18.0 and 42.0 kg/m^2
Participants with hepatic impairment (HI):
- Has a diagnosis of chronic, stable hepatic insufficiency at screening with features of cirrhosis
Healthy volunteers:
- Is medically healthy with no clinically significant medical history
All participants:
- Has a history of gastrointestinal disease which may affect food and drug absorption
- Has a history of cancer (malignancy)
- Has a positive result for human immunodeficiency virus (HIV)
- Has had major surgery and/or donated or lost significant volume of blood within 56 days prior to dosing
Participants with HI:
- Has had severe complications of liver disease within the preceding 3 months of screening
- Has a history of recent (within 3 months prior to screening) variceal bleeds
- Has evidence of hepatorenal syndrome
- Is not in sufficient health, with regard to stability of HI, to undergo participation in the study with anticipated survival of < 3 months
- Has a history of liver or other solid organ transplantation
- Has an active infection requiring systemic therapy
- Requires paracentesis more often than 2 times per month
- Has transjugular intrahepatic portosystemic shunt and/or has undergone portacaval shunting
- Has received antiviral and/or immune modulating therapy for hepatitis B virus (HBV) or hepatitis C virus (HCV) within 90 days prior to dosing
- Is using HIV protease inhibitors
- Is positive for Hepatitis B surface antigen (HBsAg)
- Is positive for HCV
Healthy volunteers:
- Has positive results for HBsAg or HCV
Study Central Contact
Contact: Toll Free Number, 1-888-577-8839, [email protected]
3 Study Locations in 1 Countries
Arizona
Arizona Clinical Trials ( Site 0003), Chandler, Arizona, 85225, United States
Study Coordinator, Contact, 210-253-3426
Recruiting
Florida
Orlando Clinical Research Center ( Site 0001), Orlando, Florida, 32809, United States
Study Coordinator, Contact, 407-240-7878
Recruiting
Texas
The Texas Liver Institute ( Site 0002), San Antonio, Texas, 78215, United States
Study Coordinator, Contact, 480-470-4000
Recruiting