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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