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Trial record 1 of 1 for:    NCT00793000
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Safety And Pharmacokinetics Study Of PF-04287881 In Healthy Adults

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ClinicalTrials.gov Identifier: NCT00793000
Recruitment Status : Completed
First Posted : November 18, 2008
Last Update Posted : May 4, 2011
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE November 12, 2008
First Posted Date  ICMJE November 18, 2008
Last Update Posted Date May 4, 2011
Study Start Date  ICMJE November 2008
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 15, 2008)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 17, 2008)
  • 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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2009)
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. ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2008)
No Secondary endpoints are identified in this protocol. See co-primary endpoints. [ Time Frame: No timeframe because there is no secondary endpoint. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety And Pharmacokinetics Study Of PF-04287881 In Healthy Adults
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Condition  ICMJE Respiratory Tract Infections
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 30, 2009)
80
Original Estimated Enrollment  ICMJE
 (submitted: November 17, 2008)
72
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00793000
Other Study ID Numbers  ICMJE B0581001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP