A Study To Investigate The Safety And Toleration Of Multiple Oral Doses Of PF-03654764 In Combination With Fexofenadine In Healthy Subjects

Study Overview
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Brief Summary
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The purpose of this study in heathy people is to investigate the safety, toleration and time course of PF-03654764 in the blood, following multiple doses given by mouth together with fexofenadine.

Official Title
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A Phase 1 Double-blind (3rd Party Open), Randomized, Placebo-controlled Study To Investigate The Safety And Toleration Of Multiple Oral Doses Of Pf-03654764 In Combination With Fexofenadine In Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: PF-03654764 2.5mg plus fexofenadine 60mg
* Drug: PF-03654764 5mg plus fexofenadine 60mg
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy subjects. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests). Exclusion Criteria: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). A positive urine drug screen. Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.

Ages Eligible for Study
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Minimum Age: 21 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

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PF-03654764 2.5mg plus fexofenadine 60mg<br> | Drug: PF-03654764 2.5mg plus fexofenadine 60mg<br>* PF-03654764 2.5mg plus fexofenadine 60mg twice daily for 7 days<br>|
| Experimental: PF-03654764 5mg plus fexofenadine 60mg<br> | Drug: PF-03654764 5mg plus fexofenadine 60mg<br>* PF-03654764 5mg plus fexofenadine 60mg twice daily for 7 days<br>|
| Placebo Comparator: placebo<br> | Drug: placebo<br>* placebo given twice daily for 7 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events as a measure of safety and tolerability. |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentrations of PF-03654764 will be measured. |  | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase 1 multiple dose safety toleration fexofenadine