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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00659555 |
Purpose
This is a two-period study to evaluate the effect of repeat oral dosing of ketoconazole on the pharmacokinetics of single dose pazopanib administered as an eye drop
| Condition | Intervention | Phase |
|---|---|---|
|
Age-Related Macular Degeneration |
Drug: pazopanib eye drops and ketoconazole tablets |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study |
| Official Title: | An Open-Label, Two-Period, Fixed-Sequence Study in Healthy Volunteers to Evaluate the Effects of Repeat Oral Dosing of Ketoconazole on the Pharmacokinetics of a Single Dose of Pazopanib (GW786034) Administered as Eye Drops |
| Enrollment: | 22 |
| Study Start Date: | April 2008 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion criteria:
A female subject is eligible to participate if she is of:
Exclusion Criteria:
Current alcohol or illicit drug use which, in the judgment of the Investigator, would interfere with the subject's ability to comply with the dosing schedule or protocol-specified evaluations. For example, a history of regular alcohol consumption (defined below) within 6 months of screening would exclude a subject.
Contacts and Locations
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | MD7110861 |
| Study First Received: | April 10, 2008 |
| Last Updated: | June 4, 2009 |
| ClinicalTrials.gov Identifier: | NCT00659555 History of Changes |
| Health Authority: | United States: Food and Drug Administration; United States: Food and Drug Administration |
|
pazopanib, age-related macular degeneration, vascular endothelial growth factor, angiogenesis, |
pharmacokinetics, drug interaction, ketoconazole |
|
Anti-Infective Agents Respiratory System Agents Sympathomimetics Eye Diseases Physiological Effects of Drugs Macular Degeneration Retinal Degeneration Cardiovascular Agents Tetrahydrozoline |
Ketoconazole Pharmacologic Actions Nasal Decongestants Autonomic Agents Antifungal Agents Therapeutic Uses Vasoconstrictor Agents Peripheral Nervous System Agents Retinal Diseases |