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Clinical Trials/NCT02130531
NCT02130531CompletedPhase 1

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

Kubota Vision Inc.1 site in 1 country26 target enrollmentStarted: April 2014Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Sponsor
Enrollment
26
Locations
1
Primary Endpoint
Area Under the Concentration-Time Curve from time zero to 24 hours [(AUC(0-24h)]

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

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

Intervention: Emixustat HCl Tablet (Drug)

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

Intervention: Placebo Tablet (Other)

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

Intervention: Emixustat HCl Tablet (Drug)

Outcomes

Primary Outcomes

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

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

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Kubota Vision Inc.
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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