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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Subcutaneous injection administered at a dose of 7 mg
Clinical Pharmacology of Miami ( Site 0005)
Miami, Florida, United States
Advanced Pharma CR, LLC ( Site 0001)
Miami, Florida, United States
Genesis Clinical Research, LLC ( Site 0006)
Tampa, Florida, United States
American Research Corporation ( Site 0002)
San Antonio, Texas, United States
Area Under the Curve From Time 0 to Infinity (AUC0-inf) of Efinopegdutide
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
Area Under the Curve From Time 0 to Last Sampling Time (AUC0-last) of Efinopegdutide
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
Maximum Plasma Concentration (Cmax) of Efinopegdutide
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
Time to Maximum Concentration (Tmax) of Efinopegdutide
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
Apparent Terminal Half-life (t/12) of Efinopegdutide
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
Apparent Total Clearance (CL/F) of Efinopegdutide
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
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Apparent Volume of Distribution (Vz/F) of Efinopegdutide
Blood samples collected at multiple timepoints post-dose were used to determine the Vz/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
Number of Participants Who Experienced an Adverse Event (AE)
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
Number of Participants Who Discontinued Study Intervention Due to an AE
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