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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.

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.

Condition or disease Intervention/treatment Phase
Geographic Atrophy Age-Related Macular Degeneration Drug: Emixustat HCl Tablet Other: Placebo Tablet Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Pharmacokinetic and Pharmacodynamic Study of Emixustat Hydrochloride in Subjects With Geographic Atrophy Associated With Dry Age-Related Macular Degeneration
Study Start Date : April 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


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 Name: 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 Name: ACU-4429




Primary Outcome Measures :
  1. 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 ]
  2. Degree of suppression of the ERG b-wave response post-photobleaching. [ Time Frame: Screening through Day 10 of each dosing period and study exit ]


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02130531


Locations
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United States, Washington
Call Acucela Clinical Trials Helpdesk for locations
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Acucela Inc.
Investigators
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Study Director: Acucela Medical Monitor Acucela Inc.

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Responsible Party: Acucela Inc.
ClinicalTrials.gov Identifier: NCT02130531     History of Changes
Other Study ID Numbers: 4429-101
First Posted: May 5, 2014    Key Record Dates
Last Update Posted: January 18, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Macular Degeneration
Geographic Atrophy
Atrophy
Retinal Degeneration
Retinal Diseases
Eye Diseases
Pathological Conditions, Anatomical