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Safety and Tolerability of ACU-4429

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ClinicalTrials.gov 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

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
Primary Completion Date : June 2009
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

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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

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

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

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