A Study of Calderasib (MK-1084) in Participants With Hepatic Impairment and Healthy Volunteers (MK-1084-017)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMerck Sharp & Dohme LLC
About this trial
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
Qualifiers
Has a body mass index (BMI) between 18.0 and 42.0 kg/m²
Has a diagnosis of chronic, stable hepatic insufficiency at screening with features of cirrhosis
Is medically healthy with no clinically significant medical history
Disqualifiers
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
Trial design
Treatments tested in this trial
- Calderasib
Treatment groups
58 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov