Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACU-4429 in Subjects With Geographic Atrophy

Overview

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of the investigational drug ACU-4429 in subjects with geographic atrophy.

Full Title of Study: “Multicenter, Randomized, Double-Masked, Placebo-Controlled, Dose Escalation, Multiple-Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACU-4429 in Subjects With Dry Age-Related Macular Degeneration (Geographic Atrophy)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 2012

Interventions

  • Drug: ACU-4429
    • ACU-4429 tablets (2, 5, 7, or 10 mg) taken orally once daily for 90 days
  • Drug: Matching placebo
    • Matching placebo tablets taken orally once daily for 90 days

Arms, Groups and Cohorts

  • Experimental: ACU-4429 tablet
  • Placebo Comparator: Matching placebo tablet

Clinical Trial Outcome Measures

Primary Measures

  • Safety as measured by: AEs, clinical laboratory tests, vital signs, physical exams, visual tests, and questionaire
    • Time Frame: Through treatment period (up to Day 90) until 1-2 weeks post last dose (Day 97-104)

Secondary Measures

  • Pharmacokinetics as measured by plasma ACU-4429 drug levels
    • Time Frame: Baseline; Treatment Days 2, 7, 14, 30, 60 and 90

Participating in This Clinical Trial

Inclusion Criteria

  • Have a clinical diagnosis of geographic atrophy, as defined in the protocol

Exclusion Criteria

  • Currently receiving or has received a medication prohibited by the protocol

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Acucela Inc.
  • Collaborator
    • Otsuka Pharmaceutical Co., Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • John W Chandler, MD, Study Director, Acucela Inc.

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