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A Safety Study in Healthy Volunteers to Evaluate Safety, How Fast the Drug is Absorbed, and the Side Effects of the Drug in Humans

2014-08-27 03:16:33 | BioPortfolio

Summary

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.

Description

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Conditions

Age Related Macular Degeneration

Intervention

GW786034, Placebo

Location

GSK Investigational Site
Minneapolis
Minnesota
United States
55404

Status

Completed

Source

GlaxoSmithKline

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:33-0400

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