Safety and Tolerability of ACU-4429

This study has been completed.
Information provided by (Responsible Party):
Acucela Inc. Identifier:
First received: June 19, 2008
Last updated: June 25, 2012
Last verified: June 2012

The purpose of this study is to evaluate the safety and tolerability of a new investigational drug (ACU-4429) in healthy human volunteers.

Condition Intervention Phase
Drug: ACU-4429
Drug: matching placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Single Center, Randomized, Double-Masked, Dose-Escalating, Placebo-Controlled Study of the Safety and Tolerability ACU-4429 in Healthy Volunteers

Further study details as provided by Acucela Inc.:

Primary Outcome Measures:
  • Safety and tolerability [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics [ Time Frame: 2 days ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: May 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug: ACU-4429
administered as a single dose, orally
Placebo Comparator: 2
matching placebo
Drug: matching placebo
administered as a single dose, orally


Ages Eligible for Study:   55 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Is male or female with age ≥ 55 and ≤ 80 years at the time of consent
  • Is healthy as determined by medical history and physical examination

Exclusion Criteria:

  • Is receiving or has recently received treatment with a medication disallowed per the protocol
  Contacts and Locations
Please refer to this study by its identifier: NCT00703183

United States, Texas
Covance Clinical Research Unit, Inc
Dallas, Texas, United States, 75247
Sponsors and Collaborators
Acucela Inc.
Principal Investigator: William W Lewis, M.D. Covance
  More Information

No publications provided

Responsible Party: Acucela Inc. Identifier: NCT00703183     History of Changes
Other Study ID Numbers: 4429-0001
Study First Received: June 19, 2008
Last Updated: June 25, 2012
Health Authority: United States: Food and Drug Administration processed this record on April 22, 2014