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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT01051700 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Age Related Macular Degeneration |
Drug: GW786034 Other: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Supportive Care |
| Official Title: | A Two-part Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Repeat Oral Doses of Pazopanib in Healthy Adult Subjects |
| Enrollment: | 72 |
| Study Start Date: | January 2010 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 10 mg
GW786034
|
Drug: GW786034
Investigational product
Other Name: pazopanib
|
|
Experimental: 20 mg
GW786034
|
Drug: GW786034
Investigational product
Other Name: pazopanib
|
|
Experimental: 5 mg
GW786034
|
Drug: GW786034
Investigational product
Other Name: pazopanib
|
| Placebo Comparator: Placebo |
Other: Placebo
Placebo
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Minnesota | |
| GSK Investigational Site | |
| Minneapolis, Minnesota, United States, 55404 | |
| United States, Texas | |
| GSK Investigational Site | |
| Austin, Texas, United States, 78744 | |
| United States, Washington | |
| GSK Investigational Site | |
| Tacoma, Washington, United States, 98418 | |
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | Study Director, GSK |
| ClinicalTrials.gov Identifier: | NCT01051700 History of Changes |
| Other Study ID Numbers: | 113555 |
| Study First Received: | January 7, 2010 |
| Last Updated: | June 10, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
GW786034 pazopanib age-related macular degeneration choroidal neovascularization vascular endothelial growth factor platelet derived growth factor |
stem cell growth factor repeat-dose safety tolerability pharmacokinetics |
|
Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases |