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Safety and Tolerability of ACU-4429

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00703183
First Posted: June 23, 2008
Last Update Posted: June 27, 2012
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.
Information provided by (Responsible Party):
Acucela Inc.
  Purpose
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
ACU-4429
Drug: ACU-4429
administered as a single dose, orally
Placebo Comparator: 2
matching placebo
Drug: matching placebo
administered as a single dose, orally

  Eligibility

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.


Ages Eligible for Study:   55 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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 ClinicalTrials.gov identifier (NCT number): NCT00703183


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

Responsible Party: Acucela Inc.
ClinicalTrials.gov Identifier: NCT00703183     History of Changes
Other Study ID Numbers: 4429-0001
First Submitted: June 19, 2008
First Posted: June 23, 2008
Last Update Posted: June 27, 2012
Last Verified: June 2012