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

June 19, 2008
June 25, 2012
May 2008
June 2009   (final data collection date for primary outcome measure)
Safety and tolerability [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00703183 on Archive Site
Pharmacokinetics [ Time Frame: 2 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
Safety and Tolerability of ACU-4429
A Single Center, Randomized, Double-Masked, Dose-Escalating, Placebo-Controlled Study of the Safety and Tolerability ACU-4429 in Healthy Volunteers

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

Not Provided
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Drug: ACU-4429
    administered as a single dose, orally
  • Drug: matching placebo
    administered as a single dose, orally
  • Experimental: 1
    Intervention: Drug: ACU-4429
  • Placebo Comparator: 2
    matching placebo
    Intervention: Drug: matching placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2009
June 2009   (final data collection date for primary outcome measure)

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
55 Years to 80 Years
Contact information is only displayed when the study is recruiting subjects
United States
Acucela Inc.
Acucela Inc.
Not Provided
Principal Investigator: William W Lewis, M.D. Covance
Acucela Inc.
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP