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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
Healthy Drug: ACU-4429 Drug: matching placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]

Secondary Outcome Measures:
  • Pharmacokinetics [ Time Frame: 2 days ]

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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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 processed this record on September 21, 2017