Status:
COMPLETED
Safety, Tolerability, Pharmacokinetics And Measurement Of Whole Blood Activity (WBA) Of PNU-100480 After Multiple Oral Doses In Healthy Adult Volunteers
Lead Sponsor:
Sequella, Inc.
Conditions:
Tuberculosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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 tubercu...
Detailed Description
Evaluate safety, tolerability, pharmacokinetics and whole blood activity (WBA) of PNU-100480 given for 14 or 28 days; evaluate WBA of PNU with pyrazinamide; evaluate WBA of linezolid
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT00990990
Start Date
October 1 2009
End Date
May 1 2010
Last Update
August 28 2013
Active Locations (1)
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1
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511