Study Evaluating BLI-489 and Piperacillin in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: BLI-489/Piperacillin; Drug: BLI-489; Drug: Piperacillin

• Registration Number: NCT00894439
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

The purpose of this study is to evaluate how BLI-489 and piperacillin interact when given together to healthy subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-05-06
• Study First Submitted QC: 2009-05-06
• Study First Posted: 2009-05-07
• Status Verified: 2009-07
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Last Update Submitted: 2009-07-16
• Last Update Posted: 2009-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Men or women of non-childbearing potential, aged 18 to 50 years of age inclusive at screening.
2. Body mass index (BMI) in the range of 18 to 32 kg/m2 and body weight greater than or equal to 50 kg.
3. Healthy as determined by the investigator on the basis of the screening evaluations.
4. Nonsmoker of smoker of fewer than 10 cigarettes per day as determined by history.

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Exclusion Criteria

1. Presence of history of any disorder that may prevent the successful completion of the study.
2. History of drug abuse within 1 year.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	BLI-489/Piperacillin	-
1	BLI-489	-
1	Piperacillin	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics as evaluated by drug concentrations in the blood and urine.	10 days

Secondary Outcome Measures

Name	Time	Method
Safety as measured by the number of adverse events and serious adverse events.	10 weeks