Safety And Pharmacokinetics Study Of PF-04287881 In Healthy Adults

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Respiratory Tract Infections

Intervention / Treatment
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* Drug: PF-04287881
* Drug: Placebo
* Drug: PF-04287881
* Drug: Placebo
* Drug: PF-04287881
* Drug: Placebo
* Drug: PF-04287881
* Drug: Placebo
* Drug: PF-04287881
* Drug: Placebo
* Drug: PF-04287881
* Drug: Placebo
* Drug: PF-04287881
* Drug: Placebo
* Drug: PF-04287881
* Drug: Placebo
* Drug: PF-04287881
* Drug: Placebo
* Drug: PF-04287881
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br> | Drug: PF-04287881<br>* 75 mg oral dose (prepared solution) given once<br>Drug: Placebo<br>* placebo to match 75 mg oral dose (prepared solution), given once<br>|
| Experimental: Cohort 2<br> | Drug: PF-04287881<br>* 150 mg oral dose (prepared solution) given once<br>Drug: Placebo<br>* placebo to match 150 mg oral dose (prepared solution), given once<br>|
| Experimental: Cohort 3<br> | Drug: PF-04287881<br>* 300 mg oral dose (prepared solution) given once<br>Drug: Placebo<br>* placebo to match 300 mg oral dose (prepared solution), given once<br>|
| Experimental: Cohort 4<br> | Drug: PF-04287881<br>* 750 mg oral dose (prepared solution) given once<br>Drug: Placebo<br>* placebo to match 750 mg oral dose (prepared solution), given once<br>|
| Experimental: Cohort 5<br> | Drug: PF-04287881<br>* 1000 mg oral dose (prepared solution) given once<br>Drug: Placebo<br>* placebo to match 1000 mg oral dose (prepared solution), given once<br>|
| Experimental: Cohort 6<br> | Drug: PF-04287881<br>* 1250 mg oral dose (prepared solution) given once<br>Drug: Placebo<br>* placebo to match 1250 mg oral dose (prepared solution), given once<br>|
| Experimental: Cohort 7<br> | Drug: PF-04287881<br>* 1500 mg oral dose (prepared solution) given once<br>Drug: Placebo<br>* placebo to match 1500 mg oral dose (prepared solution), given once<br>|
| Experimental: Cohort 8<br>Japanese volunteers, low dose previously tested (based on PK) | Drug: PF-04287881<br>* 300 mg oral dose (prepared solution) given once<br>Drug: Placebo<br>* placebo to match 300 mg oral dose (prepared solution), given once<br>|
| Experimental: Cohort 9<br>Japanese volunteers, intermediate dose previously tested (based on PK) | Drug: PF-04287881<br>* 750 mg oral dose (prepared solution) given once<br>Drug: Placebo<br>* placebo to match 750 mg oral dose (prepared solution), given once<br>|
| Experimental: Cohort 10<br>Japanese volunteers, high dose previously tested (based on safety) | Drug: PF-04287881<br>* 1000 mg based on safety and PK from previous cohorts; oral dose (prepared solution) given once<br>Drug: Placebo<br>* placebo to match 1000 mg oral dose (prepared solution), given once<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of safety and tolerability of PF-04287881 after single oral dose. |  | Daily up to discharge, follow-up 7-10 days after dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety tolerability pharmacokinetics PK first in human FIH