Safety, Tolerability And Pharmacokinetics Study Of Single Doses Of PNU-100480 In Healthy Adults
Overview
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.
Full Title of Study: “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”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Double (Participant, Investigator)
- Study Primary Completion Date: August 2009
Interventions
- Drug: PNU-100480
- 100 mg oral suspension given once
- Drug: PNU-100480
- 300 mg oral suspension given once
- Drug: Placebo
- placebo to match oral suspension given once
- Drug: PNU-100480
- 300 mg oral suspension given once
- Drug: PNU-100480
- 35 mg oral suspension given once
- Drug: Placebo
- placebo to match oral suspension given once
- Drug: PNU-100480
- 100 mg oral suspension given once
- Drug: PNU-100480
- 35 mg oral suspension given once
- Drug: Placebo
- placebo to match oral suspension given once
- Drug: PNU-100480
- 1000 mg oral suspension given once
- Drug: PNU-100480
- 1500 mg oral suspension given once
- Drug: PNU-100480
- Fed conditions, 600 mg oral suspension given once
- Drug: Placebo
- placebo to match oral suspension given once
- Drug: PNU-100480
- 1500 mg oral suspension given once
- Drug: PNU-100480
- 600 mg oral suspension given once
- Drug: PNU-100480
- Fed conditions, 600 mg oral suspension given once
- Drug: Placebo
- placebo to match oral suspension given once
- Drug: PNU-100480
- 1000 mg oral suspension given once
- Drug: PNU-100480
- 600 mg oral suspension given once
- Drug: PNU-100480
- Fed conditions, 600 mg oral suspension given once
- Drug: Placebo
- placebo to match oral suspension given once
Arms, Groups and Cohorts
- Experimental: Cohort 1, Sequence 1
- Period 1- Placebo Period 2- 100 mg Period 3- 300 mg
- Experimental: Cohort 1, Sequence 2
- Period 1- 35 mg Period 2- Placebo Period 3- 300 mg
- Experimental: Cohort 1, Sequence 3
- Period 1- 35 mg Period 2- 100 mg Period 3- Placebo
- Experimental: Cohort 2, Sequence 1
- Period 1- Placebo Period 2- 1000 mg Period 3- 1500 mg Period 4- 600 mg (Fed conditions)
- Experimental: Cohort 2, Sequence 2
- Period 1- 600 mg Period 2- Placebo Period 3- 1500 mg Period 4- 600 mg (Fed conditions)
- Experimental: Cohort 2, Sequence 3
- Period 1- 600 mg Period 2- 1000 mg Period 3- Placebo Period 4- 600 mg (Fed conditions)
Clinical Trial Outcome Measures
Primary Measures
- Evaluation of safety and tolerability of escalating single oral doses of PNU-100480.
- Time Frame: Daily, Days 1-3 or 4, and 7-14 days after dosing.
Secondary Measures
- Characterize pharmacokinetics of single oral doses PNU-100480.
- Time Frame: Predose; multiple timepoints postdose on Day 1, and up to 72 hours postdose.
- Characterize the effect of food on the pharmacokinetics of a single oral dose of PNU-100480.
- Time Frame: Predose; multiple timepoints postdose on Day 1, and up to 72 hours postdose.
- 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)
- Time Frame: Predose and timpoints up to 24 hours post dose on Day 1 (only in some periods)
Participating in This Clinical Trial
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.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 55 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Sequella, Inc.
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Lisa Beth Ferstenberg, M.D., Study Director, Sequella, Inc.
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