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Trial record 1 of 1 for:    NCT01026545
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Multiple Oral Dose Safety, Tolerability And Pharmacokinetic Study Of PF-04287881 In Healthy Adult Subjects

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ClinicalTrials.gov Identifier: NCT01026545
Recruitment Status : Completed
First Posted : December 4, 2009
Last Update Posted : May 4, 2011
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE December 3, 2009
First Posted Date  ICMJE December 4, 2009
Last Update Posted Date May 4, 2011
Study Start Date  ICMJE December 2009
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2009)
  • Standard safety assessments including assessment of AEs, laboratory tests, ECGs, and vital signs. [ Time Frame: Screening, Dosing days 1-10, through follow-up ]
  • The primary pharmacokinetic endpoints to be evaluated for PF-04287881 include Cmax, Tmax, and AUC(0-24) on Day 1 and Day 10. [ Time Frame: Day 1 and 10 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2009)
  • Secondary parameters include AUCinf and t1/2 as data permit, apparent oral clearance (CL/F), apparent volume of distribution (Vz/F) and accumulation ratio (Rac). [ Time Frame: Days 1, 5 and 10 ]
  • Urine concentrations of PF 04287881 in Cohorts 2 and 5 will be used to determine total amount excreted (Ae), %Ae relative to dose given and renal clearance (CLR). [ Time Frame: Day 10 ]
  • Concentrations of PF 04287881 will be measured in white blood cell (WBC) polymorphonuclear cells (PMNs) in Cohorts 2 and 5 to determine total exposure in WBC. [ Time Frame: Days 1 and 10 ]
  • Plasma samples from Cohort 2 will be used for exploratory investigation of circulating metabolites. [ Time Frame: Days 1 and 10 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multiple Oral Dose Safety, Tolerability And Pharmacokinetic Study Of PF-04287881 In Healthy Adult Subjects
Official Title  ICMJE A Phase 1, Double-Blind, Randomized, Placebo-Controlled Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-04287881 After Administration Of Multiple Escalating Oral Doses To Healthy Adult Subjects
Brief Summary

This study is a randomized, investigator blind, subject blind, sponsor-open, placebo controlled, multiple dose escalating, sequential, parallel cohort study of PF-04287881. Subjects will undergo screening procedures within 28 days prior to dosing. At least 1 day after the Screening visit, eligible subjects who meet the entry criteria will be admitted to the Clinical Research Unit (CRU) and confined in the unit until discharge on Day 15.

Approximately 60 healthy volunteers (20 volunteers of Japanese origin for Cohorts 5 and 6), 18 to 55 years of age, males and females (women of non childbearing potential only) will be enrolled and randomized in a 4:1 ratio to treatment with either PF-04287881 or placebo within each cohort. Each cohort will have a 10 day dosing period and each will consist of 10 subjects (8 active and 2 placebo). In each cohort, each subject will receive a single daily oral dose of either placebo or PF-04287881 under fasted state for 10 days.

Detailed Description Following a Serious Adverse Event (potential Hy's Law case), a risk-benefit assessment review of all preliminary safety data, and a review by Pfizer's internal hepatic injury advisory panel, it was concluded that PF-04287881 had an unacceptable therapeutic window. The FDA was notified of our intention to discontinue development as of 09April2010.
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
    500 mg once daily for 10 days
  • Drug: Placebo
    To match 500 mg dose once daily for 10 days
  • Drug: PF-04287881
    750 mg once daily for 10 days
  • Drug: Placebo
    To match 750 mg dose once daily for 10 days
  • Drug: PF-04287881
    1100 mg once daily for 10 days
  • Drug: Placebo
    To match 1100 mg dose once daily for 10 days
  • Drug: PF-04287881
    Optional cohort with dose not greater than 1100 mg
  • Drug: Placebo
    Optional cohort to match dose not greater than 1100 mg
  • Drug: PF-04287881
    750 mg dose once daily for 10 days
  • Drug: PF-04287881
    1100 mg dose once daily for 10 days
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 (optional)
    If intermediate or repeat dose level is needed; dose will not exceed 1100 mg.
    Interventions:
    • Drug: PF-04287881
    • Drug: Placebo
  • Experimental: Cohort 5 (Japanese)
    Interventions:
    • Drug: PF-04287881
    • Drug: Placebo
  • Experimental: Cohort 6 (Japanese)
    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: July 15, 2010)
39
Original Estimated Enrollment  ICMJE
 (submitted: December 3, 2009)
60
Actual Study Completion Date  ICMJE July 2010
Actual Primary Completion Date July 2010   (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 must 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 hypersensitivity 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 NCT01026545
Other Study ID Numbers  ICMJE B0581002
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