A Study of Efinopegdutide in Participants With Hepatic Impairment (MK-6024-014)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Efinopegdutide in Participants with Moderate Hepatic Impairment Participants with moderate hepatic impairment receive a single 7 mg dose of efinopegdutide 14 mg/ml by subcutaneous (SC) injection. |
Drug: Efinopegdutide
Subcutaneous injection administered at a dose of 7 mg
Other Names:
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| Experimental: Efinopegdutide in Participants with Severe Hepatic Impairment Participants with severe hepatic impairment receive a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection. |
Drug: Efinopegdutide
Subcutaneous injection administered at a dose of 7 mg
Other Names:
|
| Experimental: Efinopegdutide in Healthy-Matched Control Group Healthy matched participants receive a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection. |
Drug: Efinopegdutide
Subcutaneous injection administered at a dose of 7 mg
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Secondary Outcome Measures
- 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.
Eligibility Criteria
Criteria
The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
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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.
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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).
Exclusion Criteria:
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History of cancer (malignancy).
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Had major surgery and/or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the prestudy (screening) visit.
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Participants with moderate or severe hepatic impairment who are positive for human immunodeficiency virus (HIV)-1 or HIV-2 at the prestudy (screening) visit.
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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.
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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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Merck Sharp & Dohme LLC
Investigators
- Study Director: Medical Director, Merck Sharp & Dohme LLC
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 6024-014
- MK-6024-014