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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
26
Tablet for oral administration
Tablet for oral administration
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Seattle, Washington, United States
Area Under the Concentration-Time Curve from time zero to 24 hours [(AUC(0-24h)]
Time frame: Day 1 and Day 7 of each dosing period
Degree of suppression of the ERG b-wave response post-photobleaching.
Time frame: Screening through Day 10 of each dosing period and study exit
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