A Study To Estimate The Effect Of Repeated Dosing of PF-05175157 On The Pharmacokinetics Of A Single Dose Of Simvastatin In Healthy Adult Subjects

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

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2011-12-31

Brief Summary

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The study is designed to investigate the effect of repeated dosing of PF-05175157 on the pharmacokinetics of a single dose of Simvastatin in healthy adult subjects.

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Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

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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Single arm, fixed sequence dosing

Group Type EXPERIMENTAL

Simvastatin

Intervention Type DRUG

Day 1: Single dose of simvastatin 20 mg Day 8: single dose of simvastatin 20 mg (with PF-05175157)

PF-05175157

Intervention Type DRUG

Days 2-9 inclusive: daily dosing of PF-05175157 200 mg

Interventions

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Simvastatin

Day 1: Single dose of simvastatin 20 mg Day 8: single dose of simvastatin 20 mg (with PF-05175157)

Intervention Type DRUG

PF-05175157

Days 2-9 inclusive: daily dosing of PF-05175157 200 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy subjects with normal results in all screening examinations.
* Body Mass Index of 17.5 to 35.5 kg/m2

Exclusion Criteria

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, ocular, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Known history of intolerance to simvastatin or other statins.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes