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Sponsored by: |
NPS Pharmaceuticals |
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Information provided by: | NPS Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00819468 |
This is a study to compare the pharmacokinetic profile of teduglutide in healthy subjects with normal hepatic function with subjects who have moderate hepatic impairment.
Condition | Intervention | Phase |
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Hepatic Impairment |
Drug: teduglutide |
Phase I |
Study Type: | Interventional |
Study Design: | Non-Randomized, Open Label, Placebo Control, Single Group Assignment, Pharmacokinetics Study |
Official Title: | Pharmacokinetics of 20 mg Teduglutide in Subjects With Moderately Impaired Hepatic Function Compared to Healthy Subjects With Normal Hepatic Function |
Enrollment: | 24 |
Study Start Date: | July 2007 |
Study Completion Date: | December 2008 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Subjects with moderate hepatic impairment (Child-Pugh score of 7-9)
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Drug: teduglutide
20 mg dose of lypholized powder mixed with sterile water and injected subcutaneously into the abdomen.
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2: Active Comparator
Healthy volunteers with normal hepatic function matched to hepatic impaired subjects by age, gender, BMI, and renal function as measured by creatinine
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Drug: teduglutide
20 mg dose of lypholized powder mixed with sterile water and injected subcutaneously into the abdomen.
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24 subjects (equally divided between subjects 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. Subjects in both groups are matched up by sex, age, BMI, and renal function.
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Inclusion for Subjects with Impaired Hepatic Function (in addition to above criteria):
Exclusion Criteria:
United States, Florida | |
University of Miami Clinical Pharmacology Unit | |
MIami, Florida, United States, 33136 |
Study Director: | John Caminis, MD | NPS Pharmaceuticals |
Responsible Party: | NPS Pharmaceuticals ( John Wallens ) |
Study ID Numbers: | CL0600-017, CL0600-017 |
Study First Received: | January 8, 2009 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00819468 |
Health Authority: | United States: Food and Drug Administration |
Healthy |