NCT01072214

A Safety Study to Evaluate Pazopanib Eye Drops in Healthy Volunteers

A Randomized, Placebo-controlled, Double-masked, Parallel Group Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of Repeat Doses of Pazopanib Eye Drops in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 20 Years – 64 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Macular Degeneration

Interventions

Type	Name	Description
DRUG	pazopanib	gw786034
DRUG	pazopanib	gw786034
DRUG	pazopanib	gw786034
DRUG	Placebo	placebo

Timeline

• Start date: 2010-03-09
• Primary completion: 2010-06-28
• Completion: 2010-06-28
• First posted: 2010-02-22
• Last updated: 2017-11-14

Locations

1 site across 1 country: United States