Pharmacokinetic and Pharmacodynamic Study of Emixustat in Subjects With Geographic Atrophy Associated With Dry Age-Related Macular Degeneration

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Acucela Inc.; Kubota Vision Inc.

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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