A Clinical Study to Evaluate the Effect of Hepatic Impairment on the Single-Dose Pharmacokinetics of MK-1084
Merck Sharp & Dohme LLC
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
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- Yes
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 r…
Interventions
- DrugCalderasib
Oral Tablet
Locations (3)
- Arizona Clinical Trials ( Site 0003)Chandler, Arizona
- Orlando Clinical Research Center ( Site 0001)Orlando, Florida
- The Texas Liver Institute ( Site 0002)San Antonio, Texas