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

NCT02130531 | Completed Phase 1

• 1 other identifier: 4429-101
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Geographic Atrophy; Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (2)

• Area Under the Concentration-Time Curve from time zero to 24 hours [(AUC(0-24h)]

  Day 1 and Day 7 of each dosing period

• Degree of suppression of the ERG b-wave response post-photobleaching.

  Screening through Day 10 of each dosing period and study exit

Study Arms (2)

Cohort 1

EXPERIMENTAL

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; Other: Placebo Tablet

Cohort 2

EXPERIMENTAL

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

Interventions

Emixustat HCl Tablet DRUG

Tablet for oral administration

Also known as: ACU-4429

Cohort 1; Cohort 2

Placebo Tablet OTHER

Tablet for oral administration

Cohort 1

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kubota Vision Inc.: lead

Study Sites (1)

Call Acucela Clinical Trials Helpdesk for locations

Seattle, Washington, 98101, United States

Location

MeSH Terms

Conditions

Geographic Atrophy; Macular Degeneration

Interventions

emixustat

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Acucela Medical Monitor

  Kubota Vision Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2014
• First Posted: May 5, 2014
• Study Start: April 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: November 1, 2015
• Last Updated: January 18, 2016

Record last verified: 2016-01

Locations

US (1)