Safety and Tolerability of Repeat Doses of ACU-4429 in Healthy Subjects

A Phase I, Double-Masked, Multiple Rising Dose Study of ACU-4429 in Healthy Male and Female Subjects

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: ACU-4429; Drug: matching placebo tablet

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• males or females, between 25 and 55 years of age, inclusive
• within BMI range 19 to 32 kg/m2 at Screening
• in good health, determined by no clinically significant findings from medical history, 12-lead ECG, and vital signs;
• clinical laboratory evaluations (including serum for Chem-20 [fasted at least 10 hours], CBC with differential and platelet counts, PT, INR, and aPTT, and UA) within the reference range for the test laboratory, unless deemed not clinically significant by the Investigator;
• Males (or female partners of male subjects)and females must be sterile, or agree to use approved contraceptive measures throughout the study period and 45 days after the End of In House Study.
• able to comprehend and willing to sign an Informed Consent Form.

Exclusion Criteria:

• significant history or clinical manifestation of any significant metabolic, endocrine, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder (as determined by the Investigator);
• history of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator;
• history of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs, except that appendectomy, hernia repair, and/or cholecystectomy will be allowed;
• history or presence of an abnormal ECG, which, in the Investigator's opinion, is clinically significant;
• participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 30 days prior to Check-in;
• Is currently using, or has recently received treatment with a medication disallowed by the Protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ACU-4429 tablet	Drug: ACU-4429; administered orally once a day for 14 days
PLACEBO_COMPARATOR: matching placebo tablet	Drug: matching placebo tablet; administered orally once a day for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety as measured by adverse events, physical exam, ECG, vital signs, laboratory tests and visual tests	20 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics as measured by plasma ACU-4429 drug levels	16 days

Collaborators and Investigators

• Sponsor: Kubota Vision Inc.
• Collaborators: Otsuka Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: William Lewis, MD, Covance

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (ACTUAL): April 1, 2010
• Study Completion (ACTUAL): April 1, 2010

Study Registration Dates

• First Submitted: July 16, 2009
• First Submitted That Met QC Criteria: July 17, 2009
• First Posted (ESTIMATE): July 20, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): January 10, 2012
• Last Update Submitted That Met QC Criteria: January 9, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: 8211 725