Safety and Tolerability of ACU-4429

June 25, 2012 updated by: Kubota Vision Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75247
        • Covance Clinical Research Unit, Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
matching placebo
Drug: matching placebo
administered as a single dose, orally
Experimental: 1
ACU-4429
Drug: ACU-4429
administered as a single dose, orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability
Time Frame: 7 days
7 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics
Time Frame: 2 days
2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kubota Vision Inc.

Investigators

  • Principal Investigator: William W Lewis, M.D., Covance

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

June 19, 2008

First Submitted That Met QC Criteria

June 20, 2008

First Posted (Estimate)

June 23, 2008

Study Record Updates

Last Update Posted (Estimate)

June 27, 2012

Last Update Submitted That Met QC Criteria

June 25, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • 4429-0001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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