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

Pfizer1 site in 1 country36 target enrollmentJune 4, 2010

ConditionsHealthy

InterventionsPF-03654764 2.5mg plus fexofenadine 60mg PF-03654764 5mg plus fexofenadine 60mg placebo

DrugsPF-03654764 2.5mg plus fexofenadine 60mg PF-03654764 5mg plus fexofenadine 60mg placebo

Overview

Phase: Phase 1
Intervention: PF-03654764 2.5mg plus fexofenadine 60mg
Conditions: Healthy
Sponsor: Pfizer
Enrollment: 36
Locations: 1
Primary Endpoint: Number of participants with adverse events as a measure of safety and tolerability.
Status: Terminated
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

June 4, 2010

End Date

June 4, 2010

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

Eligibility Criteria

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.