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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02201511
• Other study ID #: B7441006
• Secondary ID: 2014-001214-25
• Status: Completed
• Phase: Phase 1
• First received: July 24, 2014
• Last updated: November 9, 2015
• Start date: September 2014
• Est. completion date: October 2014

Study information

• Verified date: November 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• 3 mg PF-06412562 MR tablets_Fasted
A single modified release tablet with 3 mg PF-06412562 administered after an overnight fast
• 2 x 15 mg PF-06412562 MR tablets_Fasted
Two 15 mg PF-06412562 modified release tablets administered after an overnight fast
• 2 x 15 mg PF-06412562 MR tablets_Fed
Two 15 mg PF-06412562 modified release tablets administered after a high fat breakfast
• 10 mg PF-06412562 IR tablets
a single immediate release tablet of 10 mg PF-06412562 after an overnight fast

Locations

Country	Name	City	State
Belgium	Pfizer Clinical Research Unit	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax)		0-2 days	No
Primary	Time to Reach Maximum Observed Plasma Concentration (Tmax)		0-2 days	No
Primary	Time after dose and before the first plasma concentration (Tlag)		0-2	No
Primary	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	No
Primary	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	No
Primary	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	No

External Links

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