A Phase 1, Double-Blind, Randomized, Placebo-Controlled Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PNU-100480 (PF-02341272) After Administration Of Multiple Escalating Oral Doses To Healthy Adult Subjects

Sequella, Inc.1 site in 1 country59 target enrollmentOctober 2009

ConditionsTuberculosis

InterventionsPNU-100480 Placebo Linezolid

DrugsPNU-100480 Placebo Linezolid

Overview

Phase: Phase 1
Intervention: PNU-100480
Conditions: Tuberculosis
Sponsor: Sequella, Inc.
Enrollment: 59
Locations: 1
Primary Endpoint: To evaluate the safety and tolerability of ascending oral doses of PNU-100480 administered as extemporaneously prepared suspension (EPS) over 14 and 28 days in healthy adult volunteers.
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to assess the safety, tolerability and pharmacokinetics of multiple doses of PNU-100480 given for 14 or 28 days. Killing activity against the bacterium that causes tuberculosis (TB) will also be measured. The effect of adding an additional tuberculosis (TB) agent (given for 2 days) in addition to PNU-100480 will be evaluated. Linezolid open label to determine activity in whole blood assay (WBA).

Detailed Description

Evaluate safety, tolerability, pharmacokinetics and whole blood activity (WBA) of PNU-100480 given for 14 or 28 days; evaluate WBA of PNU with pyrazinamide; evaluate WBA of linezolid

Registry

clinicaltrials.gov

Start Date

October 2009

End Date

May 2010

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sequella, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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, or any previous antibiotic use at the discretion of the investigator.
•Previous history of irritable bowel syndrome (IBS) or inflammatory bowel disease (IBD).

Arms & Interventions

To evaluate the safety and tolerability of ascending oral doses of PNU-100480 administered as extemporaneously prepared suspension (EPS) over 14 and 28 days in healthy adult volunteers.

Time Frame: Monitor adverse events daily; safety eval pre-dose, specified times , discharge, follow-up/as needed

Secondary Outcomes

To characterize the single dose and steady state pharmacokinetics of ascending oral doses of PNU-100480 administered over 14 and 28 days in healthy adult volunteers with regard to the parent drug and its metabolites.(Full and sparse PK sampling from Day 1 through final day of dosing)
To characterize the bactericidal activity in blood of orally administered PNU-100480 against intracellular M. tuberculosis in relation to blood concentrations ofPNU-100480 and its metabolites.(Full and sparse sampling from Day 1 through final day of dosing)
To characterize the effect of once a day administration of pyrazinamide for 2 days on the pharmacokinetics and bactericidal activity in blood of orally administered PNU-100480 against intracellular M. tuberculosis (Cohorts 5 and 6, Days 27-28 only).(Days 27-28 as applicable)
To characterize pharmacokinetics and bactericidal activity in blood of orally administered linezolid against intracellular M. tuberculosis following 4 days of QD dosing.(As applicable up to Day 4)