Safety, Tolerability, Pharmacokinetics And Measurement Of Whole Blood Activity (WBA) Of PNU-100480 After Multiple Oral Doses In Healthy Adult Volunteers
Information source: Pfizer
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Tuberculosis
Intervention: PNU-100480 (Drug); Placebo (Drug); PNU-100480 (Drug); Placebo (Drug); PNU-100480 (Drug); Placebo (Drug); PNU-100480 (Drug); Placebo (Drug); PNU-100480 (Drug); Placebo (Drug); PNU-100480 (Drug); Placebo (Drug); Linezolid (Drug)
Phase: Phase 1
Status: Not yet recruiting
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
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 bacteria
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).
Clinical Details
Official title: A Phase 1, Double-Blind, Randomized, Placebo-Controlled Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PNU-100480 (PF-02341272) After Administration Of Multiple Escalating Oral Doses To Healthy Adult Subjects
Study design: Other, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety Study
Primary outcome: To evaluate the safety and tolerability of ascending oral doses of PNU-100480 administered as extemporaneously prepared suspension (EPS) over 14 and 28 days in healthy adult volunteers.
Secondary outcome: To characterize the single dose and steady state pharmacokinetics of ascending oral doses of PNU-100480 administered over 14 and 28 days in healthy adult volunteers with regard to the parent drug and its metabolites.To characterize the bactericidal activity in blood of orally administered PNU-100480 against intracellular M. tuberculosis in relation to blood concentrations ofPNU-100480 and its metabolites. To characterize the effect of once a day administration of moxifloxacin for 2 days on the pharmacokinetics and bactericidal activity in blood of orally administered PNU-100480 against intracellular M. tuberculosis (Cohorts 5 and 6, Days 27-28 only). To characterize pharmacokinetics and bactericidal activity in blood of orally administered linezolid against intracellular M. tuberculosis following 4 days of QD dosing.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
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.
Locations and Contacts
Pfizer CT.gov Call Center, Phone: 1-800-718-1021 Additional Information
To obtain contact information for a study center near you, click here.
Starting date: October 2009
Ending date: May 2010
Last updated: October 6, 2009
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