Tuberculosis Clinical Trial
Official title:
A Phase 1 Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of PNU-100480 (PF-02341272) After First Time Administration Of Ascending Oral Doses To Healthy Adult Subjects Under Fed And Fasted Conditions
Verified date | August 2013 |
Source | Sequella, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of PNU-100480 (PF-02341272) after a single dose in healthy adult volunteers.
Status | Completed |
Enrollment | 19 |
Est. completion date | August 2009 |
Est. primary completion date | August 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)
Country | Name | City | State |
---|---|---|---|
United States | Pfizer Investigational Site | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Sequella, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of safety and tolerability of escalating single oral doses of PNU-100480. | Daily, Days 1-3 or 4, and 7-14 days after dosing. | Yes | |
Secondary | Characterize pharmacokinetics of single oral doses PNU-100480. | Predose; multiple timepoints postdose on Day 1, and up to 72 hours postdose. | No | |
Secondary | Characterize the effect of food on the pharmacokinetics of a single oral dose of PNU-100480. | Predose; multiple timepoints postdose on Day 1, and up to 72 hours postdose. | No | |
Secondary | Characterize the bactericidal activity in blood of orally administered PNU-100480 against intracellular Mycobacterium tuberculosis in relation to blood concentrations of PNU-100480 (and its metabolites) (some periods only) | Predose and timpoints up to 24 hours post dose on Day 1 (only in some periods) | No |
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