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Official title A Study of Calderasib (MK-1084) in Participants With Hepatic Impairment and Healthy Volunteers (MK-1084-017)
ClinicalTrials.gov ID: NCT07219550
What this study is testing
What is Calderasib?
Calderasib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for healthy.
Also referred to as MK-1084.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80. Healthy volunteers may be eligible.
You may be able to join if
- The main 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
You likely can't join if
- 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
See the full eligibility criteria
- The main 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Chandler, Arizona, United States
- Orlando, Florida, United States
- San Antonio, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chandler, Arizona, United States; Orlando, Florida, United States; San Antonio, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.