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Safety And Pharmacokinetics Study Of PF-04287881 In Healthy Adults

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00793000
First received: November 12, 2008
Last updated: May 3, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention Phase
Respiratory Tract Infections
Drug: PF-04287881
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: 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

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: November 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1 Drug: PF-04287881
75 mg oral dose (prepared solution) given once
Drug: Placebo
placebo to match 75 mg oral dose (prepared solution), given once
Experimental: Cohort 2 Drug: PF-04287881
150 mg oral dose (prepared solution) given once
Drug: Placebo
placebo to match 150 mg oral dose (prepared solution), given once
Experimental: Cohort 3 Drug: PF-04287881
300 mg oral dose (prepared solution) given once
Drug: Placebo
placebo to match 300 mg oral dose (prepared solution), given once
Experimental: Cohort 4 Drug: PF-04287881
750 mg oral dose (prepared solution) given once
Drug: Placebo
placebo to match 750 mg oral dose (prepared solution), given once
Experimental: Cohort 5 Drug: PF-04287881
1000 mg oral dose (prepared solution) given once
Drug: Placebo
placebo to match 1000 mg oral dose (prepared solution), given once
Experimental: Cohort 6 Drug: PF-04287881
1250 mg oral dose (prepared solution) given once
Drug: Placebo
placebo to match 1250 mg oral dose (prepared solution), given once
Experimental: Cohort 7 Drug: PF-04287881
1500 mg oral dose (prepared solution) given once
Drug: Placebo
placebo to match 1500 mg oral dose (prepared solution), given once
Experimental: Cohort 8
Japanese volunteers, low dose previously tested (based on PK)
Drug: PF-04287881
300 mg oral dose (prepared solution) given once
Drug: Placebo
placebo to match 300 mg oral dose (prepared solution), given once
Experimental: Cohort 9
Japanese volunteers, intermediate dose previously tested (based on PK)
Drug: PF-04287881
750 mg oral dose (prepared solution) given once
Drug: Placebo
placebo to match 750 mg oral dose (prepared solution), given once
Experimental: Cohort 10
Japanese volunteers, high dose previously tested (based on safety)
Drug: PF-04287881
1000 mg based on safety and PK from previous cohorts; oral dose (prepared solution) given once
Drug: Placebo
placebo to match 1000 mg oral dose (prepared solution), given once

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00793000

Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511-5473
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00793000     History of Changes
Other Study ID Numbers: B0581001
Study First Received: November 12, 2008
Last Updated: May 3, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Safety tolerability pharmacokinetics PK first in human FIH

Additional relevant MeSH terms:
Respiratory Tract Infections
Infection
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 23, 2014