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Clinical Trial Summary

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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT00819468
Study type Interventional
Source Takeda
Contact
Status Completed
Phase Phase 1
Start date July 26, 2007
Completion date August 23, 2007

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