Safety and Tolerability of ACU-4429

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Acucela Inc.
ClinicalTrials.gov Identifier:
NCT00703183
First received: June 19, 2008
Last updated: June 25, 2012
Last verified: June 2012
  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
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
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

Ages Eligible for Study:   55 Years to 80 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Acucela Inc.
ClinicalTrials.gov 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

ClinicalTrials.gov processed this record on July 31, 2014