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

NCT00942240 | Completed Phase 1 DMC

• 1 other identifier: 8211 725
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Safety as measured by adverse events, physical exam, ECG, vital signs, laboratory tests and visual tests

  20 days

Secondary Outcomes (1)

• Pharmacokinetics as measured by plasma ACU-4429 drug levels

  16 days

Study Arms (2)

ACU-4429 tablet

EXPERIMENTAL

Drug: ACU-4429

matching placebo tablet

PLACEBO COMPARATOR

Drug: matching placebo tablet

Interventions

ACU-4429 DRUG

administered orally once a day for 14 days

ACU-4429 tablet

matching placebo tablet DRUG

administered orally once a day for 14 days

matching placebo tablet

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kubota Vision Inc.: lead
• Otsuka Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Covance Clinical Research Unit, Inc.

Dallas, Texas, 75247, United States

Location

MeSH Terms

Interventions

emixustat

Study Officials

• William Lewis, MD

  Covance

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2009
• First Posted: July 20, 2009
• Study Start: July 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: January 10, 2012

Record last verified: 2012-01

Locations

US (1)