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

NCT01026545 | Completed Phase 1

• 1 other identifier: B0581002
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Respiratory Tract Infections

Keywords

safety; tolerability; pharmacokinetics; multiple-dose; macrolide

Outcome Measures

Primary Outcomes (2)

• Standard safety assessments including assessment of AEs, laboratory tests, ECGs, and vital signs.

  Screening, Dosing days 1-10, through follow-up

• The primary pharmacokinetic endpoints to be evaluated for PF-04287881 include Cmax, Tmax, and AUC(0-24) on Day 1 and Day 10.

  Day 1 and 10

Secondary Outcomes (4)

• Secondary parameters include AUCinf and t1/2 as data permit, apparent oral clearance (CL/F), apparent volume of distribution (Vz/F) and accumulation ratio (Rac).

  Days 1, 5 and 10

• Urine concentrations of PF 04287881 in Cohorts 2 and 5 will be used to determine total amount excreted (Ae), %Ae relative to dose given and renal clearance (CLR).

  Day 10

• Concentrations of PF 04287881 will be measured in white blood cell (WBC) polymorphonuclear cells (PMNs) in Cohorts 2 and 5 to determine total exposure in WBC.

  Days 1 and 10

• Plasma samples from Cohort 2 will be used for exploratory investigation of circulating metabolites.

  Days 1 and 10

Study Arms (6)

Cohort 1

EXPERIMENTAL

Drug: PF-04287881; Drug: Placebo

Cohort 2

EXPERIMENTAL

Drug: PF-04287881; Drug: Placebo

Cohort 3

EXPERIMENTAL

Drug: PF-04287881; Drug: Placebo

Cohort 4 (optional)

EXPERIMENTAL

If intermediate or repeat dose level is needed; dose will not exceed 1100 mg.

Drug: PF-04287881; Drug: Placebo

Cohort 5 (Japanese)

EXPERIMENTAL

Drug: PF-04287881; Drug: Placebo

Cohort 6 (Japanese)

EXPERIMENTAL

Drug: PF-04287881; Drug: Placebo

Interventions

PF-04287881 DRUG

500 mg once daily for 10 days

Cohort 1

Placebo DRUG

To match 500 mg dose once daily for 10 days

Cohort 1

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 3, 2009
• First Posted: December 4, 2009
• Study Start: December 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: May 4, 2011

Record last verified: 2011-05

Locations

US (1)