Age-Related Macular Degeneration, Geographic Atrophy
Conditions
Brief 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.
Detailed description
This is a multi-center, randomized, masked, multiple-dose, crossover study of the pharmacokinetics of emixustat hydrochloride (HCl) in subjects with geographic atrophy (GA) associated with dry age-related macular degeneration (AMD). Subjects will receive study drug during multiple dose periods in a crossover design, and serve as their own controls. There is a 21-28 day washout period between dose periods. The final Study Exit visit is 21 to 28 days after the subject's last dose of study drug at the end of the final dosing period.
Interventions
OTHERPlacebo Tablet
Tablet for oral administration
DRUGEmixustat HCl Tablet
Tablet for oral administration
Sponsors
Kubota Vision Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area Under the Concentration-Time Curve from time zero to 24 hours [(AUC(0-24h)] | Day 1 and Day 7 of each dosing period |
| Degree of suppression of the ERG b-wave response post-photobleaching. | Screening through Day 10 of each dosing period and study exit |
Countries
United States
Outcome results
None listed