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

January 14, 2016 updated by: Kubota Vision Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

26

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98101
        • Call Acucela Clinical Trials Helpdesk for locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Drug: Emixustat HCl Tablet
Tablet for oral administration
Other Names:
  • ACU-4429
Other: Placebo Tablet
Tablet for oral administration
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
Drug: Emixustat HCl Tablet
Tablet for oral administration
Other Names:
  • ACU-4429

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
Screening through Day 10 of each dosing period and study exit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kubota Vision Inc.

Investigators

  • Study Director: Acucela Medical Monitor, Kubota Vision Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (ACTUAL)

September 1, 2015

Study Completion (ACTUAL)

November 1, 2015

Study Registration Dates

First Submitted

May 1, 2014

First Submitted That Met QC Criteria

May 1, 2014

First Posted (ESTIMATE)

May 5, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

January 18, 2016

Last Update Submitted That Met QC Criteria

January 14, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4429-101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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