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

Kubota Vision

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: matching placebo tablet

Drug: ACU-4429

Study type

Interventional

Funder types

Industry

Identifiers

NCT00942240

8211 725

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

25 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.