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

NCT ID: NCT00871949

Last Updated: 2013-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2009-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Tuberculosis

Keywords

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Safety tolerability pharmacokinetics PK first in human FIH

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort 1, Sequence 1

Period 1- Placebo Period 2- 100 mg Period 3- 300 mg

Group Type EXPERIMENTAL

PNU-100480

Intervention Type DRUG

100 mg oral suspension given once

PNU-100480

Intervention Type DRUG

300 mg oral suspension given once

Placebo

Intervention Type DRUG

placebo to match oral suspension given once

Cohort 1, Sequence 2

Period 1- 35 mg Period 2- Placebo Period 3- 300 mg

Group Type EXPERIMENTAL

PNU-100480

Intervention Type DRUG

300 mg oral suspension given once

PNU-100480

Intervention Type DRUG

35 mg oral suspension given once

Placebo

Intervention Type DRUG

placebo to match oral suspension given once

Cohort 1, Sequence 3

Period 1- 35 mg Period 2- 100 mg Period 3- Placebo

Group Type EXPERIMENTAL

PNU-100480

Intervention Type DRUG

100 mg oral suspension given once

PNU-100480

Intervention Type DRUG

35 mg oral suspension given once

Placebo

Intervention Type DRUG

placebo to match oral suspension given once

Cohort 2, Sequence 1

Period 1- Placebo Period 2- 1000 mg Period 3- 1500 mg Period 4- 600 mg (Fed conditions)

Group Type EXPERIMENTAL

PNU-100480

Intervention Type DRUG

1000 mg oral suspension given once

PNU-100480

Intervention Type DRUG

1500 mg oral suspension given once

PNU-100480

Intervention Type DRUG

Fed conditions, 600 mg oral suspension given once

Placebo

Intervention Type DRUG

placebo to match oral suspension given once

Cohort 2, Sequence 2

Period 1- 600 mg Period 2- Placebo Period 3- 1500 mg Period 4- 600 mg (Fed conditions)

Group Type EXPERIMENTAL

PNU-100480

Intervention Type DRUG

1500 mg oral suspension given once

PNU-100480

Intervention Type DRUG

600 mg oral suspension given once

PNU-100480

Intervention Type DRUG

Fed conditions, 600 mg oral suspension given once

Placebo

Intervention Type DRUG

placebo to match oral suspension given once

Cohort 2, Sequence 3

Period 1- 600 mg Period 2- 1000 mg Period 3- Placebo Period 4- 600 mg (Fed conditions)

Group Type EXPERIMENTAL

PNU-100480

Intervention Type DRUG

1000 mg oral suspension given once

PNU-100480

Intervention Type DRUG

600 mg oral suspension given once

PNU-100480

Intervention Type DRUG

Fed conditions, 600 mg oral suspension given once

Placebo

Intervention Type DRUG

placebo to match oral suspension given once

Interventions

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PNU-100480

100 mg oral suspension given once

Intervention Type DRUG

PNU-100480

300 mg oral suspension given once

Intervention Type DRUG

Placebo

placebo to match oral suspension given once

Intervention Type DRUG

PNU-100480

300 mg oral suspension given once

Intervention Type DRUG

PNU-100480

35 mg oral suspension given once

Intervention Type DRUG

Placebo

placebo to match oral suspension given once

Intervention Type DRUG

PNU-100480

100 mg oral suspension given once

Intervention Type DRUG

PNU-100480

35 mg oral suspension given once

Intervention Type DRUG

Placebo

placebo to match oral suspension given once

Intervention Type DRUG

PNU-100480

1000 mg oral suspension given once

Intervention Type DRUG

PNU-100480

1500 mg oral suspension given once

Intervention Type DRUG

PNU-100480

Fed conditions, 600 mg oral suspension given once

Intervention Type DRUG

Placebo

placebo to match oral suspension given once

Intervention Type DRUG

PNU-100480

1500 mg oral suspension given once

Intervention Type DRUG

PNU-100480

600 mg oral suspension given once

Intervention Type DRUG

PNU-100480

Fed conditions, 600 mg oral suspension given once

Intervention Type DRUG

Placebo

placebo to match oral suspension given once

Intervention Type DRUG

PNU-100480

1000 mg oral suspension given once

Intervention Type DRUG

PNU-100480

600 mg oral suspension given once

Intervention Type DRUG

PNU-100480

Fed conditions, 600 mg oral suspension given once

Intervention Type DRUG

Placebo

placebo to match oral suspension given once

Intervention Type DRUG

Other Intervention Names

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Period 2 Period 3 Period 1 Period 3 Period 1 Period 2 Period 2 Period 1 Period 3 Period 2 Period 3 Period 4 (Fed) Period 1 Period 3 Period 1 Period 4 (Fed) Period 2 Period 2 Period 1 Period 4 (Fed) Period 3

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sequella, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lisa Beth Ferstenberg, M.D.

Role: STUDY_DIRECTOR

Sequella, Inc.

Locations

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Pfizer Investigational Site

New Haven, Connecticut, United States

Site Status

Countries

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United States

References

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Wallis RS, Jakubiec WM, Kumar V, Silvia AM, Paige D, Dimitrova D, Li X, Ladutko L, Campbell S, Friedland G, Mitton-Fry M, Miller PF. Pharmacokinetics and whole-blood bactericidal activity against Mycobacterium tuberculosis of single doses of PNU-100480 in healthy volunteers. J Infect Dis. 2010 Sep 1;202(5):745-51. doi: 10.1086/655471.

Reference Type DERIVED
PMID: 20629533 (View on PubMed)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1171001&StudyName=Safety%2C%20Tolerability%20And%20Pharmacokinetics%20Study%20Of%20Single%20Doses%20Of%20PNU-100480%20In%20Healthy%20Adults

To obtain contact information for a study center near you, click here.

Other Identifiers

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B1171001

Identifier Type: -

Identifier Source: org_study_id