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

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ClinicalTrials.gov Identifier: NCT00942240
Recruitment Status : Completed
First Posted : July 20, 2009
Last Update Posted : January 10, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: ACU-4429 Drug: matching placebo tablet Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase I, Double-Masked, Multiple Rising Dose Study of ACU-4429 in Healthy Male and Female Subjects
Study Start Date : July 2009
Primary Completion Date : April 2010
Study Completion Date : April 2010
Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Safety as measured by adverse events, physical exam, ECG, vital signs, laboratory tests and visual tests [ Time Frame: 20 days ]

Secondary Outcome Measures :
  1. Pharmacokinetics as measured by plasma ACU-4429 drug levels [ Time Frame: 16 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations

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): NCT00942240


Locations
United States, Texas
Covance Clinical Research Unit, Inc.
Dallas, Texas, United States, 75247
Sponsors and Collaborators
Acucela Inc.
Otsuka Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: William Lewis, MD Covance
More Information

Responsible Party: Acucela Inc.
ClinicalTrials.gov Identifier: NCT00942240     History of Changes
Other Study ID Numbers: 8211 725
First Posted: July 20, 2009    Key Record Dates
Last Update Posted: January 10, 2012
Last Verified: January 2012