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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01002950
Recruitment Status : Completed
First Posted : October 28, 2009
Last Update Posted : March 11, 2014
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Acucela Inc.

Tracking Information
First Submitted Date  ICMJE October 26, 2009
First Posted Date  ICMJE October 28, 2009
Last Update Posted Date March 11, 2014
Study Start Date  ICMJE October 2009
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 5, 2012)
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) ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 26, 2009)
Safety as measured by: AEs, clinical laboratory tests, vital signs, physical exams, and visual tests [ Time Frame: Through treatment period (up to Day 90) until 1-2 weeks post last dose (Day 97-104) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 26, 2009)
Pharmacokinetics as measured by plasma ACU-4429 drug levels [ Time Frame: Baseline; Treatment Days 2, 7, 14, 30, 60 and 90 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACU-4429 in Subjects With Geographic Atrophy
Official Title  ICMJE 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)
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Dry Age-related Macular Degeneration
  • Geographic Atrophy
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: ACU-4429 tablet
    Intervention: Drug: ACU-4429
  • Placebo Comparator: Matching placebo tablet
    Intervention: Drug: Matching placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 18, 2012)
72
Original Estimated Enrollment  ICMJE
 (submitted: October 26, 2009)
84
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01002950
Other Study ID Numbers  ICMJE 4429-201
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Acucela Inc.
Study Sponsor  ICMJE Acucela Inc.
Collaborators  ICMJE Otsuka Pharmaceutical Co., Ltd.
Investigators  ICMJE
Study Director: John W Chandler, MD Acucela Inc.
PRS Account Acucela Inc.
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP