Drug-Drug Interaction Study With PF-05089771

NCT ID: NCT01934569

Last Updated: 2014-01-16

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

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2013-11-30

Brief Summary

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This study will test the potential for PF-05089771 to interact with a cocktail of drugs

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Active tratment

Pravastatin, midazolam, losartan, omeprazole, caffeine single dose alone or in combination with PF-05089771

Group Type EXPERIMENTAL

Pravastatin, midazolam, losartan, omeprazole, caffeine and PF-05089771

Intervention Type DRUG

PF-05089771 450mg single dose and titration from 150mg BID to 450mg BID Pravastatin 10mg dingle dose, Midazolam 7.5mg single dose, Losartan 25mg single dose, Caffeine 100mg single dose, Omeprazole 20mg single dose

Interventions

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Pravastatin, midazolam, losartan, omeprazole, caffeine and PF-05089771

PF-05089771 450mg single dose and titration from 150mg BID to 450mg BID Pravastatin 10mg dingle dose, Midazolam 7.5mg single dose, Losartan 25mg single dose, Caffeine 100mg single dose, Omeprazole 20mg single dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male and/or female subjects between the ages of 18 and 55 years;
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs);

Exclusion Criteria

* Any condition possibly affecting drug absorption
* History of regular alcohol consumption
* Screening supine blood pressure \>140 mm Hg (systolic) or \>90 mm Hg (diastolic),
* Consumption of coffee, cola or other caffeine containing drinks
Minimum Eligible Age

18 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

Brussels, , Belgium

Site Status

Countries

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Belgium

Related Links

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Other Identifiers

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B3291023

Identifier Type: -

Identifier Source: org_study_id

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