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

August 26, 2013 updated by: Sequella, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1, Sequence 1
Period 1- Placebo Period 2- 100 mg Period 3- 300 mg
Drug: PNU-100480
100 mg oral suspension given once
Other Names:
  • Period 2
Drug: PNU-100480
300 mg oral suspension given once
Other Names:
  • Period 3
Drug: Placebo
placebo to match oral suspension given once
Other Names:
  • Period 3
Drug: PNU-100480
35 mg oral suspension given once
Other Names:
  • Period 1
Drug: PNU-100480
1000 mg oral suspension given once
Other Names:
  • Period 2
Drug: PNU-100480
1500 mg oral suspension given once
Other Names:
  • Period 3
Drug: PNU-100480
Fed conditions, 600 mg oral suspension given once
Other Names:
  • Period 4 (Fed)
Drug: PNU-100480
600 mg oral suspension given once
Other Names:
  • Period 1
Experimental: Cohort 1, Sequence 2
Period 1- 35 mg Period 2- Placebo Period 3- 300 mg
Drug: PNU-100480
100 mg oral suspension given once
Other Names:
  • Period 2
Drug: PNU-100480
300 mg oral suspension given once
Other Names:
  • Period 3
Drug: Placebo
placebo to match oral suspension given once
Other Names:
  • Period 3
Drug: PNU-100480
35 mg oral suspension given once
Other Names:
  • Period 1
Drug: PNU-100480
1000 mg oral suspension given once
Other Names:
  • Period 2
Drug: PNU-100480
1500 mg oral suspension given once
Other Names:
  • Period 3
Drug: PNU-100480
Fed conditions, 600 mg oral suspension given once
Other Names:
  • Period 4 (Fed)
Drug: PNU-100480
600 mg oral suspension given once
Other Names:
  • Period 1
Experimental: Cohort 1, Sequence 3
Period 1- 35 mg Period 2- 100 mg Period 3- Placebo
Drug: PNU-100480
100 mg oral suspension given once
Other Names:
  • Period 2
Drug: PNU-100480
300 mg oral suspension given once
Other Names:
  • Period 3
Drug: Placebo
placebo to match oral suspension given once
Other Names:
  • Period 3
Drug: PNU-100480
35 mg oral suspension given once
Other Names:
  • Period 1
Drug: PNU-100480
1000 mg oral suspension given once
Other Names:
  • Period 2
Drug: PNU-100480
1500 mg oral suspension given once
Other Names:
  • Period 3
Drug: PNU-100480
Fed conditions, 600 mg oral suspension given once
Other Names:
  • Period 4 (Fed)
Drug: PNU-100480
600 mg oral suspension given once
Other Names:
  • Period 1
Experimental: Cohort 2, Sequence 1
Period 1- Placebo Period 2- 1000 mg Period 3- 1500 mg Period 4- 600 mg (Fed conditions)
Drug: PNU-100480
100 mg oral suspension given once
Other Names:
  • Period 2
Drug: PNU-100480
300 mg oral suspension given once
Other Names:
  • Period 3
Drug: Placebo
placebo to match oral suspension given once
Other Names:
  • Period 3
Drug: PNU-100480
35 mg oral suspension given once
Other Names:
  • Period 1
Drug: PNU-100480
1000 mg oral suspension given once
Other Names:
  • Period 2
Drug: PNU-100480
1500 mg oral suspension given once
Other Names:
  • Period 3
Drug: PNU-100480
Fed conditions, 600 mg oral suspension given once
Other Names:
  • Period 4 (Fed)
Drug: PNU-100480
600 mg oral suspension given once
Other Names:
  • Period 1
Experimental: Cohort 2, Sequence 2
Period 1- 600 mg Period 2- Placebo Period 3- 1500 mg Period 4- 600 mg (Fed conditions)
Drug: PNU-100480
100 mg oral suspension given once
Other Names:
  • Period 2
Drug: PNU-100480
300 mg oral suspension given once
Other Names:
  • Period 3
Drug: Placebo
placebo to match oral suspension given once
Other Names:
  • Period 3
Drug: PNU-100480
35 mg oral suspension given once
Other Names:
  • Period 1
Drug: PNU-100480
1000 mg oral suspension given once
Other Names:
  • Period 2
Drug: PNU-100480
1500 mg oral suspension given once
Other Names:
  • Period 3
Drug: PNU-100480
Fed conditions, 600 mg oral suspension given once
Other Names:
  • Period 4 (Fed)
Drug: PNU-100480
600 mg oral suspension given once
Other Names:
  • Period 1
Experimental: Cohort 2, Sequence 3
Period 1- 600 mg Period 2- 1000 mg Period 3- Placebo Period 4- 600 mg (Fed conditions)
Drug: PNU-100480
100 mg oral suspension given once
Other Names:
  • Period 2
Drug: PNU-100480
300 mg oral suspension given once
Other Names:
  • Period 3
Drug: Placebo
placebo to match oral suspension given once
Other Names:
  • Period 3
Drug: PNU-100480
35 mg oral suspension given once
Other Names:
  • Period 1
Drug: PNU-100480
1000 mg oral suspension given once
Other Names:
  • Period 2
Drug: PNU-100480
1500 mg oral suspension given once
Other Names:
  • Period 3
Drug: PNU-100480
Fed conditions, 600 mg oral suspension given once
Other Names:
  • Period 4 (Fed)
Drug: PNU-100480
600 mg oral suspension given once
Other Names:
  • Period 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Daily, Days 1-3 or 4, and 7-14 days after dosing.

Secondary Outcome Measures

Outcome Measure
Time Frame
Characterize pharmacokinetics of single oral doses PNU-100480.
Time Frame: Predose; multiple timepoints postdose on Day 1, and up to 72 hours postdose.
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.
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)
Predose and timpoints up to 24 hours post dose on Day 1 (only in some periods)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sequella, Inc.

Investigators

  • Study Director: Lisa Beth Ferstenberg, M.D., Sequella, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

March 27, 2009

First Submitted That Met QC Criteria

March 27, 2009

First Posted (Estimate)

March 30, 2009

Study Record Updates

Last Update Posted (Estimate)

August 27, 2013

Last Update Submitted That Met QC Criteria

August 26, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B1171001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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