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

Pfizer logo

Pfizer

Status and phase

Terminated
Phase 1

Conditions

Healthy

Treatments

Drug: PF-03654764 2.5mg plus fexofenadine 60mg
Drug: placebo
Drug: PF-03654764 5mg plus fexofenadine 60mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT01298505
B0711006

Details and patient eligibility

About

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.

Enrollment

36 patients

Sex

All

Ages

21 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

36 participants in 3 patient groups, including a placebo group

PF-03654764 2.5mg plus fexofenadine 60mg
Experimental group
Treatment:
Drug: PF-03654764 2.5mg plus fexofenadine 60mg
PF-03654764 5mg plus fexofenadine 60mg
Experimental group
Treatment:
Drug: PF-03654764 5mg plus fexofenadine 60mg
placebo
Placebo Comparator group
Treatment:
Drug: placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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