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

Ascending Multiple Dose Study of the Safety, Tolerability, and Pharmacokinetics of BLI-489 Administered Intravenously to Healthy Subjects

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: placebo; Drug: BLI-489

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Washington
    • Tacoma, Washington, United States, 98418

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: 2; placebo	Drug: placebo
EXPERIMENTAL: 1; BLI-489	Drug: BLI-489

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 5, 2009
• Primary Completion (ACTUAL): July 24, 2009
• Study Completion (ACTUAL): July 24, 2009

Study Registration Dates

• First Submitted: May 27, 2009
• First Submitted That Met QC Criteria: May 27, 2009
• First Posted (ESTIMATE): May 28, 2009

Study Record Updates

• Last Update Posted (ACTUAL): September 27, 2018
• Last Update Submitted That Met QC Criteria: September 25, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Healthy Subjects
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; beta-Lactamase Inhibitors; BLI-489
• Other Study ID Numbers: 3219K1-1001