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A Study To Investigate The Effect Of Erythromycin On The Pharmacokinetics Of PH-797804

NCT ID: NCT01589614

Last Updated: 2012-08-17

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2012-08-31

Brief Summary

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The purpose of this study is to investigate the effect of co-administration with erythromycin on the time course of PH-797804 concentration in the blood following dosing by oral immediate release tablet formulation.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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PH-797804 6 mg

Subjects will receive a single 6 mg dose in the fed state

Group Type EXPERIMENTAL

PH-797804

Intervention Type DRUG

Tablet, 6mg, single

PH-797804 6 mg + erythromycin 800 mg

Subjects will receive multiple 800 mg doses of erythromycin and a single 6 mg dose of PH-797804 in the fed state

Group Type EXPERIMENTAL

PH-797804 + erythromycin

Intervention Type DRUG

PH-797804: tablet, 6mg, single erythromycin: tablet, 400 mg, multiple

Interventions

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PH-797804

Tablet, 6mg, single

Intervention Type DRUG

PH-797804 + erythromycin

PH-797804: tablet, 6mg, single erythromycin: tablet, 400 mg, multiple

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male subjects and/or healthy female subjects of non-child bearing potential between the ages of 21 and 55 years (inclusive). Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurements, 12-lead ECG and clinical laboratory tests.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \> 50 kg (110 lbs).

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.
* History of regular alcohol consumption exceeding 21 drinks/week for males.
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 Investigational Site

Singapore, Singapore, Singapore

Site Status

Countries

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Singapore

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6631036&StudyName=A%20Study%20To%20Investigate%20The%20Effect%20Of%20Erythromycin%20On%20The%20Pharmacokinetics%20Of%20PH-797804%20

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

Other Identifiers

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A6631036

Identifier Type: -

Identifier Source: org_study_id