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This study is to evaluate the safety, absorption rate and side effects associated with the study drug. Healthy volunteers will be given a single dose of the drug in Part 1. Subjects will be dosed at the same time at several different sites. In Part 2 of the study elderly volunteers will participate in a 14 day repeat dose session receiving either study drug or a placebo (sugar pill). Data from at least 7 days of safety will be reviewed from the first set of volunteers before increasing the doses for the next set. All results will be used for planning the next study.
The purpose of this study is to characterize more fully the safety, tolerability and pharmacokinetics of single and repeat oral doses of pazopanib at lower doses than those previously studied. The first part of the study is designed as an open-label, non-randomized, single session, parallel-group, sequential dose-rising to investigate pharmacokinetics of single oral doses in healthy adult subjects. In the second part of the study, healthy elderly subjects will participate in one 14 day repeat-dose session, randomized to receive either pazopanib or placebo. Dose escalation within Part 2, is based upon emerging safety and PK data from each preceding repeat dosing cohort from at least 7 days of safety data as well as emerging safety and PK data from single dose. The elderly population chosen for the second part of the study will more closely reflect the target population for the AMD indication. The results from the current study will assist in the dose selection of the subsequently planned study in patients with AMD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5 mg | Experimental | GW786034 |
|
| 10 mg | Experimental | GW786034 |
|
| 20 mg | Experimental | GW786034 |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GW786034 | Drug | Investigational product |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical safety data from AE reporting, clinical observations, physical exam findings, cardiac monitoring, vital signs, clinical laboratory tests, Pharmacokinetics, general ophthalmic examination and best-corrected visual acuity will be summarized. | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters: AUC vs time curve after single dose; AUC vs time curve, trough plasma pazopanib concentration, accumulation ratio, and apparent terminal half-life after repeat dose will be analyzed, as data permit | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Minneapolis | Minnesota | 55404 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24113783 | Derived | McLaughlin MM, Paglione MG, Slakter J, Tolentino M, Ye L, Xu CF, Suttle AB, Kim RY. Initial exploration of oral pazopanib in healthy participants and patients with age-related macular degeneration. JAMA Ophthalmol. 2013 Dec;131(12):1595-601. doi: 10.1001/jamaophthalmol.2013.5002. |
| Label | URL |
|---|---|
| Results for study 113555 can be found on the GSK Clinical Study Register. | View source |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D020256 | Choroidal Neovascularization |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D015862 | Choroid Diseases |
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| ID | Term |
|---|---|
| C516667 | pazopanib |
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| Placebo | Other | Placebo |
|
| Austin |
| Texas |
| 78744 |
| United States |
| GSK Investigational Site | Tacoma | Washington | 98418 | United States |
| D014603 |
| Uveal Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |