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Safety And Pharmacokinetics Study Of PF-04287881 In Healthy Adults

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00793000
First Posted: November 18, 2008
Last Update Posted: May 4, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
November 12, 2008
November 18, 2008
May 4, 2011
November 2008
December 2009   (Final data collection date for primary outcome measure)
Evaluation of safety and tolerability of PF-04287881 after single oral dose. [ Time Frame: Daily up to discharge, follow-up 7-10 days after dosing ]
  • Pharmacokinetics of PF-04287881 after a single oral dose. [ Time Frame: Pre-dose; Multiple timepoints on Day 1; Single sample on Days 2-5; Day 6 and 7, if needed. ]
  • Evaluation of safety and tolerability of PF-04287881 after single oral dose. [ Time Frame: Daily up to discharge, follow-up 7-10 days after dosing ]
Complete list of historical versions of study NCT00793000 on ClinicalTrials.gov Archive Site
Pharmacokinetics of PF-04287881 after a single oral dose. [ Time Frame: Pre-dose; Multiple timepoints on Day 1; 24, 36 hours Day 2; Single sample on Days 3-7. ]
No Secondary endpoints are identified in this protocol. See co-primary endpoints. [ Time Frame: No timeframe because there is no secondary endpoint. ]
Not Provided
Not Provided
 
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