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
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 April 15, 2014