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Safety and Tolerability of ACU-4429

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00703183
Recruitment Status : Completed
First Posted : June 23, 2008
Last Update Posted : June 27, 2012
Information provided by (Responsible Party):
Acucela Inc.

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

Condition or disease Intervention/treatment Phase
Healthy Drug: ACU-4429 Drug: matching placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
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
Study Start Date : May 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Safety and tolerability [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. Pharmacokinetics [ Time Frame: 2 days ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00703183

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

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Responsible Party: Acucela Inc. Identifier: NCT00703183    
Other Study ID Numbers: 4429-0001
First Posted: June 23, 2008    Key Record Dates
Last Update Posted: June 27, 2012
Last Verified: June 2012