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Multiple Oral Dose Safety, Tolerability And Pharmacokinetic Study Of PF-04287881 In Healthy Adult Subjects

Last updated on May 10, 2018

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Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511 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 must 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 hypersensitivity to macrolides or ketolides.

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

NCT01026545
Pfizer
Completed
Multiple Oral Dose Safety, Tolerability And Pharmacokinetic Study Of PF-04287881 In Healthy Adult Subjects

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Multiple Oral Dose Safety, Tolerability And Pharmacokinetic Study Of PF-04287881 In Healthy Adult Subjects
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

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.

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.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Respiratory Tract Infections
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
July 2010
July 2010   (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 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).
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
 
 
NCT01026545
B0581002
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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