Safety And Pharmacokinetics Study Of PF-04287881 In Healthy Adults

Respiratory Tract Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00793000
• Other study ID #: B0581001
• Status: Completed
• Phase: Phase 1
• First received: November 12, 2008
• Last updated: May 3, 2011
• Start date: November 2008
• Est. completion date: December 2009

Study information

• Verified date: May 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Respiratory Tract Infections

Intervention

Drug:
• PF-04287881
75 mg oral dose (prepared solution) given once
• Placebo
placebo to match 75 mg oral dose (prepared solution), given once
• PF-04287881
150 mg oral dose (prepared solution) given once
• Placebo
placebo to match 150 mg oral dose (prepared solution), given once
• PF-04287881
300 mg oral dose (prepared solution) given once
• Placebo
placebo to match 300 mg oral dose (prepared solution), given once
• PF-04287881
750 mg oral dose (prepared solution) given once
• Placebo
placebo to match 750 mg oral dose (prepared solution), given once
• PF-04287881
1000 mg oral dose (prepared solution) given once
• Placebo
placebo to match 1000 mg oral dose (prepared solution), given once
• PF-04287881
1250 mg oral dose (prepared solution) given once
• Placebo
placebo to match 1250 mg oral dose (prepared solution), given once
• PF-04287881
1500 mg oral dose (prepared solution) given once
• Placebo
placebo to match 1500 mg oral dose (prepared solution), given once
• PF-04287881
300 mg oral dose (prepared solution) given once
• Placebo
placebo to match 300 mg oral dose (prepared solution), given once
• PF-04287881
750 mg oral dose (prepared solution) given once
• Placebo
placebo to match 750 mg oral dose (prepared solution), given once
• PF-04287881
1000 mg based on safety and PK from previous cohorts; oral dose (prepared solution) given once
• Placebo
placebo to match 1000 mg oral dose (prepared solution), given once

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of safety and tolerability of PF-04287881 after single oral dose.		Daily up to discharge, follow-up 7-10 days after dosing	Yes
Secondary	Pharmacokinetics of PF-04287881 after a single oral dose.		Pre-dose; Multiple timepoints on Day 1; 24, 36 hours Day 2; Single sample on Days 3-7.	No

External Links

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