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A Safety Study to Evaluate Pazopanib Eye Drops in Healthy Volunteers

2014-08-27 03:15:47 | BioPortfolio

Summary

A study to determine the safety and tolerability of pazopanib eye drops. The study will also determine how the drug is absorbed and metabolized over time. Repeat doses of eye drops will be administered to healthy adult volunteers over a 14-day period with one additional dose given on the 15th day of the session. Three groups of subjects may receive either active drug or placebo (drops without drug). The first group of subjects will receive a maximum of 1.6mg of pazopanib or placebo. The dose of drug to be given to the next two groups will be determined based on the results of the first group of subjects. The last group of subjects will be of Japanese descent.

Description

The purpose of this study is to characterize the ocular safety and tolerability, the systemic safety and tolerability, and the pharmacokinetic profile of repeat doses of a higher strength ophthalmic formulation of pazopanib, 10 mg/mL. The higher strength formulation provides an opportunity to increase the total daily dose of pazopanib administered. In this 3-cohort study, healthy adult volunteers will participate in one 14-day repeat-dose session (plus a single dose on day 15), randomized to receive either pazopanib eye drops or placebo. Subjects in cohort 1 will receive 1 drop four times daily for a calculated total daily dose of 1.6 mg. The dosage regimen for two subsequent cohorts will be determined based on the emerging safety profile. The Japanese population chosen for the third cohort will provide a safety and tolerability profile as well as the pharmacokinetic profile of pazopanib prior to further development of this formulation in Japanese patients with AMD.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Macular Degeneration

Intervention

pazopanib, pazopanib, pazopanib, Placebo

Status

Not yet recruiting

Source

GlaxoSmithKline

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:47-0400

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Medical and Biotech [MESH] Definitions

A form of MACULAR DEGENERATION also known as dry macular degeneration marked by occurrence of a well-defined progressive lesion or atrophy in the central part of the RETINA called the MACULA LUTEA. It is distinguishable from WET MACULAR DEGENERATION in that the latter involves neovascular exudates.

A retrogressive pathological change in the retina, focal or generalized, caused by genetic defects, inflammation, trauma, vascular disease, or aging. Degeneration affecting predominantly the macula lutea of the retina is MACULAR DEGENERATION. (Newell, Ophthalmology: Principles and Concepts, 7th ed, p304)

Specialized ophthalmic technique used in the surgical repair and or treatment of disorders that include retinal tears or detachment; MACULAR HOLES; hereditary retinal disease; AIDS-related retinal infections; ocular tumors; MACULAR DEGENERATION; DIABETIC RETINOPATHY; and UVEITIS.

A form of RETINAL DEGENERATION in which abnormal CHOROIDAL NEOVASCULARIZATION occurs under the RETINA and MACULA LUTEA, causing bleeding and leaking of fluid. This leads to bulging and or lifting of the macula and the distortion or destruction of central vision.

Degenerative changes in the RETINA usually of older adults which results in a loss of vision in the center of the visual field (the MACULA LUTEA) because of damage to the retina. It occurs in dry and wet forms.

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