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
This trial accepts healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Calderasib
DrugOral Tablet
Treatment groups
58 Participants
are divided into 1 treatment groupGroup A: CalderasibExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
At designated timepoints up to approximately 7 days post-dose2
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.
Time frame
At designated timepoints up to approximately 7 days post-dose3
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.
Time frame
Up to approximately 24 hours post-dose4
Maximum Observed Drug Concentration (Cmax) of Calderasib
Blood samples will be collected to determine the Cmax of calderasib in plasma.
Time frame
At designated timepoints up to approximately 7 days post-doseSecondary outcomes
1
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.
Time frame
Up to approximately 14 days2
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.
Time frame
Up to approximately 14 daysSponsors and contacts
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Source ClinicalTrials.gov