A Study of Efinopegdutide in Participants With Hepatic Impairment (MK-6024-014)
- Conditions
- Non-alcoholic SteatohepatitisHepatic Impairment
- Interventions
- Registration Number
- NCT06052566
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
The purpose of this study is to evaluate the pharmacokinetics of efinopegdutide in participants with hepatic impairment compared to healthy participants, and to examine the safety and tolerability of efinopegdutide.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
- A participant assigned female at birth is eligible to participate if not pregnant or breastfeeding, is not a participant of childbearing potential (POCBP), or is a POCBP and agrees to follow contraceptive guidance during the study intervention period and for at least 35 days after the last dose of study intervention.
- For participants with moderate or severe hepatic impairment: Have a diagnosis of chronic (>6 months), stable, hepatic impairment with features of cirrhosis due to any etiology (stability of hepatic disease should correspond to no acute episodes of illness within the previous 2 months due to deterioration in hepatic function).
- History of cancer (malignancy).
- Had major surgery and/or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the prestudy (screening) visit.
- Participants with moderate or severe hepatic impairment who are positive for human immunodeficiency virus (HIV)-1 or HIV-2 at the prestudy (screening) visit.
- Participants with moderate or severe hepatic impairment who received antiviral and/or immune modulating therapy for hepatitis B virus (HBV) or hepatitis C virus (HCV) within 90 days prior to study start.
- Healthy participants who are unable to refrain from or anticipate the use of any medication, including prescription and nonprescription drugs or herbal remedies beginning approximately 2 weeks (or 5 half-lives) prior to administration of the initial dose of study intervention, throughout the study (including washout intervals between treatment periods), until the poststudy visit.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Efinopegdutide in Participants with Moderate Hepatic Impairment Efinopegdutide Participants with moderate hepatic impairment receive a single 7 mg dose of efinopegdutide 14 mg/ml by subcutaneous (SC) injection. Efinopegdutide in Healthy-Matched Control Group Efinopegdutide Healthy matched participants receive a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection. Efinopegdutide in Participants with Severe Hepatic Impairment Efinopegdutide Participants with severe hepatic impairment receive a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.
- Primary Outcome Measures
Name Time Method Area Under the Curve From Time 0 to Infinity (AUC0-inf) of Efinopegdutide Day 1, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35 Blood samples collected at multiple timepoints post-dose will be used to determine the AUC0-inf.
Time to Maximum Concentration (Tmax) of Efinopegdutide Day 1, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35 Blood samples collected at multiple timepoints post-dose will be used to determine the t½.
Area Under the Curve From Time 0 to Last Sampling Time (AUC0-last) of Efinopegdutide Day 1, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35 Blood samples collected at multiple timepoints post-dose will be used to determine the AUC0-last.
Apparent Volume of Distribution (Vz/F) of Efinopegdutide Day 1, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35 Blood samples collected at multiple timepoints post-dose will be used to determine the Vz/F.
Maximum Plasma Concentration (Cmax) of Efinopegdutide Day 1, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35 Blood samples collected at multiple timepoints post-dose will be used to determine the Cmax.
Apparent Total Clearance (CL/F) of Efinopegdutide Day 1, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35 Blood samples collected at multiple timepoints post-dose will be used to determine the CL/F.
- Secondary Outcome Measures
Name Time Method Number of Participants Who Experience an Adverse Event (AE) Up to approximately 35 days An AE is defined as any untoward medical occurrence associated with the use of a drug in a participant, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product and does not imply any judgment about causality.
Number of Participants Who Discontinue Study Intervention Due to an AE Up to approximately 35 days An AE is defined as any untoward medical occurrence associated with the use of a drug in a participant, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product and does not imply any judgment about causality.
Trial Locations
- Locations (4)
Clinical Pharmacology of Miami ( Site 0005)
🇺🇸Miami, Florida, United States
American Research Corporation ( Site 0002)
🇺🇸San Antonio, Texas, United States
Advanced Pharma CR, LLC ( Site 0001)
🇺🇸Miami, Florida, United States
Genesis Clinical Research, LLC ( Site 0006)
🇺🇸Tampa, Florida, United States