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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Two dose periods in any sequence (subjects will be assigned to 1 of 2 possible sequences):
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| Cohort 2 | Experimental | Three dose periods in any sequence (subjects will be assigned to 1 of 6 possible sequences):
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emixustat HCl Tablet | Drug | Tablet for oral administration |
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| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Acucela Medical Monitor | Kubota Vision Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Call Acucela Clinical Trials Helpdesk for locations | Seattle | Washington | 98101 | United States |
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| Placebo Tablet | Other | Tablet for oral administration |
|
| ID | Term |
|---|---|
| D057092 | Geographic Atrophy |
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C000592692 | emixustat |
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