NCT00871949

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 30, 2009

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

August 27, 2013

Status Verified

August 1, 2013

Enrollment Period

4 months

First QC Date

March 27, 2009

Last Update Submit

August 26, 2013

Conditions

Tuberculosis

Keywords

Safety tolerability pharmacokinetics PK first in human FIH

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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)

Study Arms (6)

Cohort 1, Sequence 1

EXPERIMENTAL

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

Drug: PNU-100480Drug: Placebo

Cohort 1, Sequence 2

EXPERIMENTAL

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

Drug: PNU-100480Drug: Placebo

Cohort 1, Sequence 3

EXPERIMENTAL

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

Drug: PNU-100480Drug: Placebo

Cohort 2, Sequence 1

EXPERIMENTAL

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

Drug: PNU-100480Drug: Placebo

Cohort 2, Sequence 2

EXPERIMENTAL

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

Drug: PNU-100480Drug: Placebo

Cohort 2, Sequence 3

EXPERIMENTAL

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

Drug: PNU-100480Drug: Placebo

Interventions

PNU-100480DRUG

100 mg oral suspension given once

Also known as: Period 2
Cohort 1, Sequence 1
PlaceboDRUG

placebo to match oral suspension given once

Also known as: Period 1
Cohort 1, Sequence 1

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • History of hypersensitivity to, or intolerance of, linezolid.
  • Antibiotic treatment within 14 days prior to dosing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Location

Related Publications (1)

  • 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.

    PMID: 20629533DERIVED

Related Links

MeSH Terms

Conditions

Tuberculosis

Interventions

PNU-100480

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Lisa Beth Ferstenberg, M.D.

    Sequella, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2009

First Posted

March 30, 2009

Study Start

April 1, 2009

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

August 27, 2013

Record last verified: 2013-08

Locations

US(1)