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OpenTrials
Completed

NCT Number: NCT00703183

Safety and Tolerability of ACU-4429

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

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Key information

Conditions

Age range

55 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit, Inc

Dallas, Texas, 75247, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ACU-4429

Drug

administered as a single dose, orally

Matching Placebo

Drug

administered as a single dose, orally

Primary outcomes

  1. Safety and tolerability

    Time frame: 7 days

Secondary outcomes

  1. Pharmacokinetics

    Time frame: 2 days

Sponsors and collaborators

Lead sponsor

Kubota Vision Inc.

Industry

Registry information

Official study title

A Single Center, Randomized, Double-Masked, Dose-Escalating, Placebo-Controlled Study of the Safety and Tolerability ACU-4429 in Healthy Volunteers

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 23, 2008
Registry last updated
Jun 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.