This is a study to compare the pharmacokinetic profile of teduglutide in healthy participants with normal hepatic function with participants who have moderate hepatic impairment.
24 participants (equally divided between participants with normal hepatic function and those with moderate hepatic impairment (defined by the protocol as a Child-Pugh classification of grade B score of 7-9)will be given a single injection of teduglutide (20mg) through subcutaneous injection into the abdomen. Blood samples would be taken within 30 minutes of dose through 24 hours post-dose. Participants in both groups are matched up by sex, age, BMI, and renal function.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
24
Participants will receive 20 mg dose of lypholized powder of teduglutide mixed with sterile water and injected subcutaneously into the abdomen.
University of Miami Clinical Pharmacology Unit
Miami, Florida, United States
Area Under the Concentration-Time Curve From Time Zero to Time of the Last Measurable Concentration (AUC0-last)
AUC0-last of Teduglutide will be evaluated.
Time frame: Pre-dose, 3 hours and 24 hours post-dose
Maximum concentration (Cmax)
Cmax of Teduglutide will be evaluated.
Time frame: Pre-dose, 3 hours and 24 hours post-dose
Elimination Half-Life (t1/2)
t1/2 of Teduglutide will be evaluated.
Time frame: Pre-dose, 3 hours and 24 hours post-dose
Number of participants with Adverse events (AEs)
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical/medicinal product which includes an exacerbation of a pre-existing illness, sign, symptom, or clinically significant laboratory test abnormality that is detected or diagnosed after study drug administration, pretreatment or post-treatment events that occur as a result of protocol-mandated procedures. An AE does not necessarily have to have a causal relationship with study drug.
Time frame: From start of study treatment to follow up (up to 9 days)
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