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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BLI-489; Drug: placebo

• Registration Number: NCT00909688
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-05-27
• Study First Submitted QC: 2009-05-27
• Study First Posted: 2009-05-28
• Study Start: 2009-06-05
• Primary Completion: 2009-07-24
• Study Completion: 2009-07-24
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-25
• Last Update Posted: 2018-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	BLI-489	BLI-489
2	placebo	placebo

Primary Outcome Measures

Name	Time	Method
Assess safety of drug given to healthy subjects by evaluating any reported adverse events (AEs), scheduled physical examinations, vital sign measurements, 12-lead ECGs, and clinical laboratory test results.	4 months