Study to Evaluate Whether BLI-489 Can be Safely Tolerated by Healthy Subjects Given Multiple Doses

NCT ID: NCT00909688

Last Updated: 2018-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-05
• Study Completion Date: 2009-07-24

Brief Summary

To determine the safety, tolerability, and drug absorption profile of multiple IV doses of BLI 489 in healthy subjects.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

1

BLI-489

Group Type: EXPERIMENTAL

BLI-489

Intervention Type: DRUG

2

placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Interventions

BLI-489

Intervention Type: DRUG

placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Men or women of non-childbearing potential (WONCBP) aged 18 to 50 years inclusive at screening;
• Body mass index (BMI) in the range of 18 to 32 kg/m2 and body weight ≥50 kg.;
• Healthy as determined by the investigator on the basis of screening evaluations;
• Calculated creatinine clearance within normal limits using the Cockcroft-Gault formula;
• Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history, and if a smoker must be able to abstain from smoking during the inpatient stay;
• Have a high probability for compliance with and completion of the study.

Exclusion Criteria

• Presence or history of any disorder that may prevent the successful completion of the study;
• Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease;
• Any surgical or medical condition that may interfere with the distribution, metabolism, or excretion of the investigational product;
• Acute disease state (eg, nausea, vomiting, fever, or diarrhea) within 7 days before study day 1;
• History of drug abuse within 1 year before study day 1;
• Admitted alcohol abuse or history of alcohol use that may interfere with the subject's ability to comply with the protocol requirements.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Locations

Tacoma, Washington, United States

Countries

United States

Other Identifiers

3219K1-1001

Identifier Type: -

Identifier Source: org_study_id