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Sponsored by: |
Pfizer |
---|---|
Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00692341 |
This study will evaluate the effects of mild and moderate impairment of hepatic function on the single-dose pharmacokinetics, safety and tolerability of AG-013736.
Condition | Intervention | Phase |
---|---|---|
Hepatic Insufficiency |
Drug: AG-013736 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study |
Official Title: | A Phase 1 Study To Evaluate The Pharmacokinetics Of AG-013736 In Subjects With Impaired Hepatic Function |
Enrollment: | 24 |
Study Start Date: | May 2008 |
Study Completion Date: | October 2008 |
Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Hepatic Function - Mild Impairment: Experimental
Subjects with mild hepatic impairment (Child Pugh class A, score 5-6)
|
Drug: AG-013736
Single oral 5-mg dose of AG-013736, administered as a film-coated, immediate-release tablet.
|
Hepatic Function - Moderate Impairment: Experimental
Subjects with moderate hepatic impairment(Child Pugh class B,score 7-9)
|
Drug: AG-013736
Single oral 5-mg dose of AG-013736, administered as a film-coated, immediate-release tablet.
|
Hepatic Function - Normal: Experimental
Group 1 1) subjects with normal hepatic function |
Drug: AG-013736
Single oral 5-mg dose of AG-013736, administered as a film-coated, immediate-release tablet.
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Florida | |
Pfizer Investigational Site | |
Orlando, Florida, United States, 32809 | |
Pfizer Investigational Site | |
Miami, Florida, United States, 33169 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A4061036 |
Study First Received: | June 4, 2008 |
Last Updated: | December 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00692341 History of Changes |
Health Authority: | United States: Food and Drug Administration |
hepatic impairment |
Liver Diseases Digestive System Diseases Hepatic Insufficiency |
Liver Diseases Digestive System Diseases Hepatic Insufficiency |