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Completed

NCT Number: NCT00871949

Safety, Tolerability And Pharmacokinetics Study Of Single Doses Of PNU-100480 In Healthy Adults

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.

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Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Mycobacterium Infections

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PNU-100480

Drug

100 mg oral suspension given once

Other names: Period 2

Placebo

Drug

placebo to match oral suspension given once

Other names: Period 1

Primary outcomes

  1. 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 outcomes

  1. Characterize pharmacokinetics of single oral doses PNU-100480.

    Time frame: Predose; multiple timepoints postdose on Day 1, and up to 72 hours postdose.

  2. 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.

  3. 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)

Sponsors and collaborators

Lead sponsor

Sequella, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Mar 30, 2009
Registry last updated
Aug 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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