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

Primary Purpose

Geographic Atrophy, Age-Related Macular Degeneration

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Emixustat HCl Tablet
Placebo Tablet
Sponsored by
Kubota Vision Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Geographic Atrophy

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Call Acucela Clinical Trials Helpdesk for locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2

Arm Description

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

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

Outcomes

Primary Outcome Measures

Area Under the Concentration-Time Curve from time zero to 24 hours [(AUC(0-24h)]
Degree of suppression of the ERG b-wave response post-photobleaching.

Secondary Outcome Measures

Full Information

First Posted
May 1, 2014
Last Updated
January 14, 2016
Sponsor
Kubota Vision Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02130531
Brief Title
Pharmacokinetic and Pharmacodynamic Study of Emixustat in Subjects With Geographic Atrophy Associated With Dry Age-Related Macular Degeneration
Official Title
Pharmacokinetic and Pharmacodynamic Study of Emixustat Hydrochloride in Subjects With Geographic Atrophy Associated With Dry Age-Related Macular Degeneration
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kubota Vision Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Geographic Atrophy, Age-Related Macular Degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
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
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Emixustat HCl Tablet
Other Intervention Name(s)
ACU-4429
Intervention Description
Tablet for oral administration
Intervention Type
Other
Intervention Name(s)
Placebo Tablet
Intervention Description
Tablet for oral administration
Primary Outcome Measure Information:
Title
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
Title
Degree of suppression of the ERG b-wave response post-photobleaching.
Time Frame
Screening through Day 10 of each dosing period and study exit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Acucela Medical Monitor
Organizational Affiliation
Kubota Vision Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Call Acucela Clinical Trials Helpdesk for locations
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States

12. IPD Sharing Statement

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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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