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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00871949

Enrollment

Registered

2009-03-30

Start date

2009-04-30

Completion date

2009-08-31

Last updated

2013-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculosis

Keywords

Safety tolerability pharmacokinetics PK first in human FIH

Brief summary

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.

Interventions

DRUGPNU-100480

100 mg oral suspension given once

DRUGPlacebo

placebo to match oral suspension given once

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
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.

Secondary

Measure	Time frame
Characterize pharmacokinetics of single oral doses PNU-100480.	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.	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)	Predose and timpoints up to 24 hours post dose on Day 1 (only in some periods)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026