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

NCT00909688 | Completed Phase 1

• 1 other identifier: 3219K1-1001
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

1

EXPERIMENTAL

BLI-489

Drug: BLI-489

2

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

BLI-489 DRUG

1

placebo DRUG

2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Unknown Facility

Tacoma, Washington, 98418, United States

Location

MeSH Terms

Interventions

BLI-489

Study Officials

• Medical Monitor

  Wyeth is now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2009
• First Posted: May 28, 2009
• Study Start: June 5, 2009
• Primary Completion: July 24, 2009
• Study Completion: July 24, 2009
• Last Updated: September 27, 2018

Record last verified: 2018-09

Locations

US (1)