NCT07219550 A Study of Calderasib (MK-1084) in Participants With Hepatic Impairment and Healthy Volunteers (MK-1084-017)
| NCT ID | NCT07219550 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Merck Sharp & Dohme LLC |
| Condition | Healthy |
| Study Type | INTERVENTIONAL |
| Enrollment | 58 participants |
| Start Date | 2025-11-05 |
| Primary Completion | 2026-08-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 58 participants in total. It began in 2025-11-05 with a primary completion date of 2026-08-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 tolerate it.
Eligibility Criteria
The main inclusion criteria include but are not limited to: 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 The main exclusion criteria include but are not limited to: 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
Contact & Investigator
Medical Director
STUDY DIRECTOR
Merck Sharp & Dohme LLC
Frequently Asked Questions
Who can join the NCT07219550 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Healthy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07219550 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07219550 currently recruiting?
Yes, NCT07219550 is actively recruiting participants. Contact the research team at Trialsites@msd.com for enrollment information.
Where is the NCT07219550 trial being conducted?
This trial is being conducted at Chandler, United States, Orlando, United States, San Antonio, United States.
Who is sponsoring the NCT07219550 clinical trial?
NCT07219550 is sponsored by Merck Sharp & Dohme LLC. The principal investigator is Medical Director at Merck Sharp & Dohme LLC. The trial plans to enroll 58 participants.