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

Age-Related Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02130531
• Other study ID #: 4429-101
• Status: Completed
• Phase: Phase 1
• First received: May 1, 2014
• Last updated: January 14, 2016
• Start date: April 2014
• Est. completion date: November 2015

Study information

• Verified date: January 2016
• Source: Acucela Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: November 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Atrophy
• Geographic Atrophy
• Macular Degeneration

Intervention

Drug:
• Emixustat HCl Tablet
Tablet for oral administration

Other:
• Placebo Tablet
Tablet for oral administration

Locations

Country	Name	City	State
United States	Call Acucela Clinical Trials Helpdesk for locations	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Acucela Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Concentration-Time Curve from time zero to 24 hours [(AUC(0-24h)]		Day 1 and Day 7 of each dosing period	No
Primary	Degree of suppression of the ERG b-wave response post-photobleaching.		Screening through Day 10 of each dosing period and study exit	No