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Pharmacokinetic and Pharmacodynamic Study of Emixustat in Subjects With Geographic Atrophy Associated With Dry Age-Related Macular Degeneration

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ClinicalTrials.gov Identifier: NCT02130531
Recruitment Status : Completed
First Posted : May 5, 2014
Last Update Posted : January 18, 2016
Sponsor:
Information provided by (Responsible Party):
Acucela Inc.

Tracking Information
First Submitted Date  ICMJE May 1, 2014
First Posted Date  ICMJE May 5, 2014
Last Update Posted Date January 18, 2016
Study Start Date  ICMJE April 2014
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2014)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 1, 2014)
  • 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 ]
  • Pharmacodynamic variables will include ERG b-wave responses pre- and post-photobleaching. [ Time Frame: Screening through Day 10 of each dosing period and study exit ]
Change History Complete list of historical versions of study NCT02130531 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetic and Pharmacodynamic Study of Emixustat in Subjects With Geographic Atrophy Associated With Dry Age-Related Macular Degeneration
Official Title  ICMJE Pharmacokinetic and Pharmacodynamic Study of Emixustat Hydrochloride in Subjects With Geographic Atrophy Associated With Dry Age-Related Macular Degeneration
Brief Summary 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.
Detailed Description 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Geographic Atrophy
  • Age-Related Macular Degeneration
Intervention  ICMJE
  • Drug: Emixustat HCl Tablet
    Tablet for oral administration
    Other Name: ACU-4429
  • Other: Placebo Tablet
    Tablet for oral administration
Study Arms  ICMJE
  • Experimental: 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
    Interventions:
    • Drug: Emixustat HCl Tablet
    • Other: Placebo Tablet
  • Experimental: 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
    Intervention: Drug: Emixustat HCl Tablet
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: May 1, 2014)
26
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males or females age ≥65 years
  • 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:

  • Geographic atrophy associated with a condition other than AMD
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (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 NCT02130531
Other Study ID Numbers  ICMJE 4429-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Acucela Inc.
Study Sponsor  ICMJE Acucela Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Acucela Medical Monitor Acucela Inc.
PRS Account Acucela Inc.
Verification Date January 2016

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