Safety, Tolerability, Pharmacokinetics And Measurement Of Whole Blood Activity (WBA) Of PNU-100480 After Multiple Oral Doses In Healthy Adult Volunteers
NCT ID: NCT00990990
Last Updated: 2013-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
59 participants
INTERVENTIONAL
2009-10-31
2010-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DOUBLE
Study Groups
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Cohort 1
PNU-100480
100 mg BID for 14 days
Placebo
to match 100 mg BID for 14 days
Cohort 2
PNU-100480
300 mg BID for 14 days
Placebo
to match 300 mg BID for 14 days
Cohort 3
PNU-100480
600 mg BID for 14 days
Placebo
to match 600 mg BID for 14 days
Cohort 4
PNU-100480
1200 mg QD for 14 days
Placebo
to match 1200 mg QD for 14 days
Cohort 5
PNU-100480
600 mg BID for 28 days with pyrazinamide (25 mg/kg up to 2 g) QD on Days 27-28
Placebo
placebo to match 600 mg BID for 28 days with pyrazinamide (25 mg/kg up to 2 g) QD on Days 27-28
Cohort 6 (optional)
PNU-100480
PNU-100480 dose up to total of 1200 mg daily for 28 days with pyrazinamide (25 mg/kg up to 2 g) QD on Days 27-28
Placebo
placebo to match dose up to total of 1200 mg daily for 28 days with pyrazinamide (25 mg/kg up to 2 g) QD on Days 27-28
Linezolid Cohort
Linezolid
300 mg QD for 4 days (open label)
Interventions
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PNU-100480
100 mg BID for 14 days
Placebo
to match 100 mg BID for 14 days
PNU-100480
300 mg BID for 14 days
Placebo
to match 300 mg BID for 14 days
PNU-100480
600 mg BID for 14 days
Placebo
to match 600 mg BID for 14 days
PNU-100480
1200 mg QD for 14 days
Placebo
to match 1200 mg QD for 14 days
PNU-100480
600 mg BID for 28 days with pyrazinamide (25 mg/kg up to 2 g) QD on Days 27-28
Placebo
placebo to match 600 mg BID for 28 days with pyrazinamide (25 mg/kg up to 2 g) QD on Days 27-28
PNU-100480
PNU-100480 dose up to total of 1200 mg daily for 28 days with pyrazinamide (25 mg/kg up to 2 g) QD on Days 27-28
Placebo
placebo to match dose up to total of 1200 mg daily for 28 days with pyrazinamide (25 mg/kg up to 2 g) QD on Days 27-28
Linezolid
300 mg QD for 4 days (open label)
Eligibility Criteria
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Inclusion Criteria
* Women of non-childbearing potential only.
Exclusion Criteria
* 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).
18 Years
55 Years
ALL
Yes
Sponsors
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Sequella, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Lisa Beth Ferstenberg, M.D.
Role: STUDY_DIRECTOR
Sequella, Inc.
Locations
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Pfizer Investigational Site
New Haven, Connecticut, United States
Countries
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References
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Wallis RS, Jakubiec WM, Kumar V, Silvia AM, Paige D, Dimitrova D, Li X, Ladutko L, Campbell S, Friedland G, Mitton-Fry M, Miller PF. Pharmacokinetics and whole-blood bactericidal activity against Mycobacterium tuberculosis of single doses of PNU-100480 in healthy volunteers. J Infect Dis. 2010 Sep 1;202(5):745-51. doi: 10.1086/655471.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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B1171002
Identifier Type: -
Identifier Source: org_study_id