A Healthy Volunteer Trial to Gain Information About the Blood Concentrations of PF-06412562 After Oral Administration of a Modified Release Formulation in Fasted and Fed Conditions

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

2014-09-30

Study Completion Date

2014-10-31

Brief Summary

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The study is designed to understand the blood concetration of PF-06412562 and its metabolite, PF-06663872, following a single oral dose of a modified release formulation. The study will include two doses of the PF-06412562 modified release formulation to understand the proportionality. Effect of food on absorption of PF-06412562 from the modified release formulation will also be investigated in this study.

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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

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Arm 1

Group Type EXPERIMENTAL

3 mg PF-06412562 MR tablets_Fasted

Intervention Type DRUG

A single modified release tablet with 3 mg PF-06412562 administered after an overnight fast

2

Group Type EXPERIMENTAL

2 x 15 mg PF-06412562 MR tablets_Fasted

Intervention Type DRUG

Two 15 mg PF-06412562 modified release tablets administered after an overnight fast

3

Group Type EXPERIMENTAL

2 x 15 mg PF-06412562 MR tablets_Fed

Intervention Type DRUG

Two 15 mg PF-06412562 modified release tablets administered after a high fat breakfast

4

Group Type EXPERIMENTAL

10 mg PF-06412562 IR tablets

Intervention Type DRUG

a single immediate release tablet of 10 mg PF-06412562 after an overnight fast

Interventions

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3 mg PF-06412562 MR tablets_Fasted

A single modified release tablet with 3 mg PF-06412562 administered after an overnight fast

Intervention Type DRUG

2 x 15 mg PF-06412562 MR tablets_Fasted

Two 15 mg PF-06412562 modified release tablets administered after an overnight fast

Intervention Type DRUG

2 x 15 mg PF-06412562 MR tablets_Fed

Two 15 mg PF-06412562 modified release tablets administered after a high fat breakfast

Intervention Type DRUG

10 mg PF-06412562 IR tablets

a single immediate release tablet of 10 mg PF-06412562 after an overnight fast

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male and/or female subjects of non-childbearing potential between the ages of 18 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 measurement, 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.
* Subjects who have attempted suicide in the past.
* Subjects who have an unexplained history of sudden death in their family

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes