Safety And Pharmacokinetics Study Of PF-04287881 In Healthy Adults

Pfizer

Status and phase: Completed; Phase 1

Conditions: Respiratory Tract Infections

Treatments: Drug: PF-04287881; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00793000

B0581001

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

80 participants in 10 patient groups

Cohort 1

Experimental group

Treatment:

Drug: Placebo

Drug: Placebo

Drug: PF-04287881

Drug: PF-04287881

Drug: Placebo

Drug: PF-04287881

Drug: Placebo

Drug: PF-04287881

Drug: Placebo

Drug: PF-04287881

Drug: PF-04287881

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: PF-04287881

Drug: PF-04287881

Drug: Placebo

Drug: PF-04287881

Drug: PF-04287881

Cohort 2

Experimental group

Treatment:

Drug: Placebo

Drug: Placebo

Drug: PF-04287881

Drug: PF-04287881

Drug: Placebo

Drug: PF-04287881

Drug: Placebo

Drug: PF-04287881

Drug: Placebo

Drug: PF-04287881

Drug: PF-04287881

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: PF-04287881

Drug: PF-04287881

Drug: Placebo

Drug: PF-04287881

Drug: PF-04287881

Cohort 3

Experimental group

Treatment:

Drug: Placebo

Drug: Placebo

Drug: PF-04287881

Drug: PF-04287881

Drug: Placebo

Drug: PF-04287881

Drug: Placebo

Drug: PF-04287881

Drug: Placebo

Drug: PF-04287881

Drug: PF-04287881

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: PF-04287881

Drug: PF-04287881

Drug: Placebo

Drug: PF-04287881

Drug: PF-04287881

Cohort 4

Experimental group

Treatment:

Drug: Placebo

Drug: Placebo

Drug: PF-04287881

Drug: PF-04287881

Drug: Placebo

Drug: PF-04287881

Drug: Placebo

Drug: PF-04287881

Drug: Placebo

Drug: PF-04287881

Drug: PF-04287881

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: PF-04287881

Drug: PF-04287881

Drug: Placebo

Drug: PF-04287881

Drug: PF-04287881

Cohort 5

Experimental group

Treatment:

Drug: Placebo

Drug: Placebo

Drug: PF-04287881

Drug: PF-04287881

Drug: Placebo

Drug: PF-04287881

Drug: Placebo

Drug: PF-04287881

Drug: Placebo

Drug: PF-04287881

Drug: PF-04287881

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: PF-04287881

Drug: PF-04287881

Drug: Placebo

Drug: PF-04287881

Drug: PF-04287881

Cohort 6

Experimental group

Treatment:

Drug: Placebo

Drug: Placebo

Drug: PF-04287881

Drug: PF-04287881

Drug: Placebo

Drug: PF-04287881

Drug: Placebo

Drug: PF-04287881

Drug: Placebo

Drug: PF-04287881

Drug: PF-04287881

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: PF-04287881

Drug: PF-04287881

Drug: Placebo

Drug: PF-04287881

Drug: PF-04287881

Cohort 7

Experimental group

Treatment:

Drug: Placebo

Drug: Placebo

Drug: PF-04287881

Drug: PF-04287881

Drug: Placebo

Drug: PF-04287881

Drug: Placebo

Drug: PF-04287881

Drug: Placebo

Drug: PF-04287881

Drug: PF-04287881

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: PF-04287881

Drug: PF-04287881

Drug: Placebo

Drug: PF-04287881

Drug: PF-04287881

Cohort 8

Experimental group

Description:

Japanese volunteers, low dose previously tested (based on PK)

Treatment:

Drug: Placebo

Drug: Placebo

Drug: PF-04287881

Drug: PF-04287881

Drug: Placebo

Drug: PF-04287881

Drug: Placebo

Drug: PF-04287881

Drug: Placebo

Drug: PF-04287881

Drug: PF-04287881

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: PF-04287881

Drug: PF-04287881

Drug: Placebo

Drug: PF-04287881

Drug: PF-04287881

Cohort 9

Experimental group

Description:

Japanese volunteers, intermediate dose previously tested (based on PK)

Treatment:

Drug: Placebo

Drug: Placebo

Drug: PF-04287881

Drug: PF-04287881

Drug: Placebo

Drug: PF-04287881

Drug: Placebo

Drug: PF-04287881

Drug: Placebo

Drug: PF-04287881

Drug: PF-04287881

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: PF-04287881

Drug: PF-04287881

Drug: Placebo

Drug: PF-04287881

Drug: PF-04287881

Cohort 10

Experimental group

Description:

Japanese volunteers, high dose previously tested (based on safety)

Treatment:

Drug: Placebo

Drug: Placebo

Drug: PF-04287881

Drug: PF-04287881

Drug: Placebo

Drug: PF-04287881

Drug: Placebo

Drug: PF-04287881

Drug: Placebo

Drug: PF-04287881

Drug: PF-04287881

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: PF-04287881

Drug: PF-04287881

Drug: Placebo

Drug: PF-04287881

Drug: PF-04287881