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Safety And Pharmacokinetics Study Of PF-04287881 In Healthy Adults

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511-5473 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Respiratory Tract Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Volunteers willing and able to be confined to the Clinical Research Unit and comply
with study schedule.

- Women of non-childbearing potential only.

- Japanese subjects muct have 4 Japanese grandparents who were born in Japan.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Previous antibiotic use within 14 days prior to dosing.

- Use of antibiotics during hospitalization within 90 days prior to dosing.

- History of sensitivity to macrolides or ketolides.

- Presence of clinically significant eye conditions (other than corrective lenses).

NCT00793000
Pfizer
Completed
Safety And Pharmacokinetics Study Of PF-04287881 In Healthy Adults

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Safety And Pharmacokinetics Study Of PF-04287881 In Healthy Adults
A Phase 1 Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-04287881 After First Time Administration Of Ascending Single Oral Doses To Healthy Adult Subjects
The purpose of this study is to determine the safety, tolerability and pharmacokinetics of PF-04287881 after a single oral dose in healthy adult volunteers.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Respiratory Tract Infections
  • Drug: PF-04287881
    75 mg oral dose (prepared solution) given once
  • Drug: Placebo
    placebo to match 75 mg oral dose (prepared solution), given once
  • Drug: PF-04287881
    150 mg oral dose (prepared solution) given once
  • Drug: Placebo
    placebo to match 150 mg oral dose (prepared solution), given once
  • Drug: PF-04287881
    300 mg oral dose (prepared solution) given once
  • Drug: Placebo
    placebo to match 300 mg oral dose (prepared solution), given once
  • Drug: PF-04287881
    750 mg oral dose (prepared solution) given once
  • Drug: Placebo
    placebo to match 750 mg oral dose (prepared solution), given once
  • Drug: PF-04287881
    1000 mg oral dose (prepared solution) given once
  • Drug: Placebo
    placebo to match 1000 mg oral dose (prepared solution), given once
  • Drug: PF-04287881
    1250 mg oral dose (prepared solution) given once
  • Drug: Placebo
    placebo to match 1250 mg oral dose (prepared solution), given once
  • Drug: PF-04287881
    1500 mg oral dose (prepared solution) given once
  • Drug: Placebo
    placebo to match 1500 mg oral dose (prepared solution), given once
  • Drug: PF-04287881
    1000 mg based on safety and PK from previous cohorts; oral dose (prepared solution) given once
  • Experimental: Cohort 1
    Interventions:
    • Drug: PF-04287881
    • Drug: Placebo
  • Experimental: Cohort 2
    Interventions:
    • Drug: PF-04287881
    • Drug: Placebo
  • Experimental: Cohort 3
    Interventions:
    • Drug: PF-04287881
    • Drug: Placebo
  • Experimental: Cohort 4
    Interventions:
    • Drug: PF-04287881
    • Drug: Placebo
  • Experimental: Cohort 5
    Interventions:
    • Drug: PF-04287881
    • Drug: Placebo
  • Experimental: Cohort 6
    Interventions:
    • Drug: PF-04287881
    • Drug: Placebo
  • Experimental: Cohort 7
    Interventions:
    • Drug: PF-04287881
    • Drug: Placebo
  • Experimental: Cohort 8
    Japanese volunteers, low dose previously tested (based on PK)
    Interventions:
    • Drug: PF-04287881
    • Drug: Placebo
  • Experimental: Cohort 9
    Japanese volunteers, intermediate dose previously tested (based on PK)
    Interventions:
    • Drug: PF-04287881
    • Drug: Placebo
  • Experimental: Cohort 10
    Japanese volunteers, high dose previously tested (based on safety)
    Interventions:
    • Drug: PF-04287881
    • Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
December 2009
December 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Volunteers willing and able to be confined to the Clinical Research Unit and comply with study schedule.
  • Women of non-childbearing potential only.
  • Japanese subjects muct have 4 Japanese grandparents who were born in Japan.

Exclusion Criteria:

  • Previous antibiotic use within 14 days prior to dosing.
  • Use of antibiotics during hospitalization within 90 days prior to dosing.
  • History of sensitivity to macrolides or ketolides.
  • Presence of clinically significant eye conditions (other than corrective lenses).
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00793000
B0581001
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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