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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02201511

Enrollment

Registered

2014-07-28

Start date

2014-09-30

Completion date

2014-10-31

Last updated

2015-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

relative bioavailbility, food effect, pharmacokinetics, ALTERATION OF COGNITIVE FUNCTIONS

Brief 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.

Interventions

DRUG3 mg PF-06412562 MR tablets_Fasted

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

DRUG2 x 15 mg PF-06412562 MR tablets_Fasted

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

DRUG2 x 15 mg PF-06412562 MR tablets_Fed

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

DRUG10 mg PF-06412562 IR tablets

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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]	0- 2 days	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).
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]	0-2 days	AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)
Plasma Decay Half-Life (t1/2)	0-2 days	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026