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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

NCT ID: NCT01298505

Last Updated: 2019-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-04

Study Completion Date

2010-06-04

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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PF-03654764 2.5mg plus fexofenadine 60mg

Group Type EXPERIMENTAL

PF-03654764 2.5mg plus fexofenadine 60mg

Intervention Type DRUG

PF-03654764 2.5mg plus fexofenadine 60mg twice daily for 7 days

PF-03654764 5mg plus fexofenadine 60mg

Group Type EXPERIMENTAL

PF-03654764 5mg plus fexofenadine 60mg

Intervention Type DRUG

PF-03654764 5mg plus fexofenadine 60mg twice daily for 7 days

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo given twice daily for 7 days

Interventions

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PF-03654764 2.5mg plus fexofenadine 60mg

PF-03654764 2.5mg plus fexofenadine 60mg twice daily for 7 days

Intervention Type DRUG

PF-03654764 5mg plus fexofenadine 60mg

PF-03654764 5mg plus fexofenadine 60mg twice daily for 7 days

Intervention Type DRUG

placebo

placebo given twice daily for 7 days

Intervention Type DRUG

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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Clinical Research Unit

Singapore, , Singapore

Site Status

Countries

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Singapore

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B0711006&StudyName=A%20Study%20To%20Investigate%20The%20Safety%20And%20Toleration%20Of%20Multiple%20Oral%20Doses%20Of%20PF-03654764%20In%20Combination%20With%20Fexofenadine%20In%20Healthy%20Sub

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

Other Identifiers

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B0711006

Identifier Type: -

Identifier Source: org_study_id

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