Safety, Tolerability, Pharmacokinetics And Measurement Of Whole Blood Activity (WBA) Of PNU-100480 After Multiple Oral Doses In Healthy Adult Volunteers - NCT00990990-06511(Clinical Trial 443074)
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New Haven |
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State:
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CT |
| Zip Code: |
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06511 |
| Conditions: |
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Tuberculosis |
| Purpose: |
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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).
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| Study summary: |
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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 |
| Criteria: |
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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). |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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July 2, 2010 |
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