Pharmacokinetic and Pharmacodynamic Study of Emixustat in Subjects With Geographic Atrophy Associated With Dry Age-Related Macular Degeneration
NCT ID: NCT02130531
Last Updated: 2016-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
26 participants
INTERVENTIONAL
2014-04-30
2015-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Cohort 1
Two dose periods in any sequence (subjects will be assigned to 1 of 2 possible sequences):
* Emixustat HCl Tablet Strength B (mid dose); 1 tablet once daily \& 1 placebo tablet once daily for 7 days
* Emixustat HCl Tablet Strength A (low dose); 1 tablet twice daily for 7 days
Emixustat HCl Tablet
Tablet for oral administration
Placebo Tablet
Tablet for oral administration
Cohort 2
Three dose periods in any sequence (subjects will be assigned to 1 of 6 possible sequences):
* Emixustat HCl Tablet Strength A (low dose); 1 tablet daily for 7 days
* Emixustat HCl Tablet Strength B (mid dose); 1 tablet daily for 7 days
* Emixustat HCl Tablet Strength C (high dose); 1 tablet daily for 7 days
Emixustat HCl Tablet
Tablet for oral administration
Interventions
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Emixustat HCl Tablet
Tablet for oral administration
Placebo Tablet
Tablet for oral administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
65 Years
ALL
No
Sponsors
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Kubota Vision Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Acucela Medical Monitor
Role: STUDY_DIRECTOR
Kubota Vision Inc.
Locations
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Seattle, Washington, United States
Countries
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Other Identifiers
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4429-101
Identifier Type: -
Identifier Source: org_study_id
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