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

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sequella, Inc.
• Treatments: Linezolid; Oxazolidinones; Pyrazinamide

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).