Pharmacokinetic and Pharmacodynamic Study of Emixustat in Subjects With Geographic Atrophy Associated With Dry Age-Related Macular Degeneration
Completed · Phase 1 · Has a placebo group
Conditions studied: Geographic Atrophy, Age-Related Macular Degeneration
In brief
The purpose of this study is to characterize emixustat hydrochloride pharmacokinetic and pharmacodynamic parameters in subjects with geographic atrophy associated with dry age-related macular degeneration.
Key facts
- Study ID
- NCT02130531
- Run by
- Kubota Vision Inc.
- People needed
- 26
- Starts
- 2014-04-01
- Expected to finish
- 2015-11-01
- Last updated by the study team
- 2016-01-18
Who can join
Age: 65 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Males or females age ≥65 years
- Clinical diagnosis of GA associated with AMD
- Able and willing to provide written informed consent
- Able to reliably administer oral medication by self or with available assistance
You may not qualify if…
- Geographic atrophy associated with a condition other than AMD
- History of, active or high risk of developing choroidal neovascularization (CNV) in either eye
- Known serious allergy to the fluorescein sodium for injection in angiography
- Pre-specified laboratory abnormalities at screening
- Treatment with any investigational study drug within 30 days of screening or device within 60 days of screening
- Prior participation in any clinical study of emixustat
- History of other disease, metabolic dysfunction, chronic immunosuppression, physical examination finding
- Male subjects who are not surgically sterile and are not willing to practice a medically accepted method of birth control with their female partner of childbearing potential from screening through 21 days after the last dose of study drug
Where it is running
- Call Acucela Clinical Trials Helpdesk for locations — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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