Drug-Drug Interaction Study With PF-05089771

January 15, 2014 updated by: Pfizer

Evaluation Of The Effect Of PF-05089771 On The Metabolism Of Multiple Cytochrome P450 And OATP1B1 Transporter Substrates

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, B-1070
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Active tratment
Pravastatin, midazolam, losartan, omeprazole, caffeine single dose alone or in combination with PF-05089771
Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Observed Plasma Concentration (Cmax)
Time Frame: 24h
24h
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Time Frame: 24h
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
24h
Minimum Observed Plasma Trough Concentration (Cmin)
Time Frame: 24h
24h
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time Frame: 24h
24h

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Lipid Parameters
Time Frame: 14 days
Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations.
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (ACTUAL)

November 1, 2013

Study Completion (ACTUAL)

November 1, 2013

Study Registration Dates

First Submitted

August 29, 2013

First Submitted That Met QC Criteria

August 29, 2013

First Posted (ESTIMATE)

September 4, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

January 16, 2014

Last Update Submitted That Met QC Criteria

January 15, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B3291023

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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