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

This study has been completed.
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Acucela Inc.
ClinicalTrials.gov Identifier:
NCT00942240
First received: July 16, 2009
Last updated: January 9, 2012
Last verified: January 2012
  Purpose

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 Intervention Phase
Healthy
Drug: ACU-4429
Drug: matching placebo tablet
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase I, Double-Masked, Multiple Rising Dose Study of ACU-4429 in Healthy Male and Female Subjects

Further study details as provided by Acucela Inc.:

Primary Outcome Measures:
  • Safety as measured by adverse events, physical exam, ECG, vital signs, laboratory tests and visual tests [ Time Frame: 20 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics as measured by plasma ACU-4429 drug levels [ Time Frame: 16 days ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: July 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   25 Years to 55 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Acucela Inc.
ClinicalTrials.gov Identifier: NCT00942240     History of Changes
Other Study ID Numbers: 8211 725
Study First Received: July 16, 2009
Last Updated: January 9, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 29, 2014