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

A Phase 1, Open-label Study In Healthy Subjects To Investigate the Pharmacokinetics Of Pf-06412562 Following Single Oral Administration Of Modified Release Formulation In Fasted And Fed States

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: 3 mg PF-06412562 MR tablets_Fasted; Drug: 2 x 15 mg PF-06412562 MR tablets_Fasted; Drug: 2 x 15 mg PF-06412562 MR tablets_Fed; Drug: 10 mg PF-06412562 IR tablets

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, B-1070
    • Pfizer Clinical Research Unit

Participation Criteria

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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1	Drug: 3 mg PF-06412562 MR tablets_Fasted; A single modified release tablet with 3 mg PF-06412562 administered after an overnight fast
Experimental: 2	Drug: 2 x 15 mg PF-06412562 MR tablets_Fasted; Two 15 mg PF-06412562 modified release tablets administered after an overnight fast
Experimental: 3	Drug: 2 x 15 mg PF-06412562 MR tablets_Fed; Two 15 mg PF-06412562 modified release tablets administered after a high fat breakfast
Experimental: 4	Drug: 10 mg PF-06412562 IR tablets; a single immediate release tablet of 10 mg PF-06412562 after an overnight fast

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Observed Plasma Concentration (Cmax)		0-2 days
Time to Reach Maximum Observed Plasma Concentration (Tmax)		0-2 days
Time after dose and before the first plasma concentration (Tlag)		0-2
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf]	AUC (0 - inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time. It is obtained from AUC (0 - t) plus AUC (t - inf).	0- 2 days
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]	AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)	0-2 days
Plasma Decay Half-Life (t1/2)	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.	0-2 days

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: July 24, 2014
• First Submitted That Met QC Criteria: July 24, 2014
• First Posted (Estimate): July 28, 2014

Study Record Updates

• Last Update Posted (Estimate): November 10, 2015
• Last Update Submitted That Met QC Criteria: November 9, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: pharmacokinetics; food effect; relative bioavailbility; ALTERATION OF COGNITIVE FUNCTIONS
• Other Study ID Numbers: B7441006; 2014-001214-25 (EudraCT Number)