Efinopegdutide
DrugSubcutaneous injection administered at a dose of 7 mg
Other names: MK-6024, HM12525A, JNJ-64565111
NCT Number: NCT06052566
The purpose of this study was to evaluate the pharmacokinetics of efinopegdutide in participants with hepatic impairment compared to healthy participants, and to examine the safety and tolerability of efinopegdutide.
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Notify Me18 year–75 year
All sexes
Interventional
Phase 1
Advanced Pharma CR, LLC ( Site 0001), Miami, Florida, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion criteria
Exclusion criteria
Subcutaneous injection administered at a dose of 7 mg
Other names: MK-6024, HM12525A, JNJ-64565111
Time frame: At pre-specified timepoints on Day 1, Day 2, Day 3, 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 were used to determine the AUC0-inf.
Time frame: At pre-specified timepoints on Day 1, Day 2, Day 3, 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 were used to determine the AUC0-last.
Time frame: At pre-specified timepoints on Day 1, Day 2, Day 3, 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 were used to determine the Cmax.
Time frame: At pre-specified timepoints on Day 1, Day 2, Day 3, 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 were used to determine the Tmax of efinopegdutide.
Time frame: At pre-specified timepoints on Day 1, Day 2, Day 3, 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 were used to determine the t1/2.
Time frame: At pre-specified timepoints on Day 1, Day 2, Day 3, 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 were used to determine the CL/F.
Time frame: At pre-specified timepoints on Day 1, Day 2, Day 3, 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 were used to determine the Vz/F.
Time frame: Up to 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.
Time frame: Up to 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.
Merck Sharp & Dohme LLC
Industry
An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of Efinopegdutide (MK-6024) in Participants With Moderate and Severe Hepatic Impairment
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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