Safety, Tolerability, Pharmacokinetics And Measurement Of Whole Blood Activity (WBA) Of PNU-100480 After Multiple Oral Doses In Healthy Adult Volunteers

Completed · Phase 1 · Has a placebo group

Conditions studied: Tuberculosis

In brief

The purpose of this study is to assess the safety, tolerability and pharmacokinetics of multiple doses of PNU-100480 given for 14 or 28 days. Killing activity against the bacterium that causes tuberculosis (TB) will also be measured. The effect of adding an additional tuberculosis (TB) agent (given for 2 days) in addition to PNU-100480 will be evaluated. Linezolid open label to determine activity in whole blood assay (WBA).

Key facts

Study ID

NCT00990990

Run by

Sequella, Inc.

People needed

59

Starts

2009-10-01

Expected to finish

2010-05-01

Last updated by the study team

2013-08-28

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy adult volunteers willing and able to be confined to the Clinical Research Unit and comply with study schedule.
• Women of non-childbearing potential only.

You may not qualify if…

• History of hypersensitivity to, or intolerance of, linezolid.
• Antibiotic treatment within 14 days prior to dosing, or any previous antibiotic use at the discretion of the investigator.
• Previous history of irritable bowel syndrome (IBS) or inflammatory bowel disease (IBD).

Where it is running

• Pfizer Investigational Site — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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