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Completed

NCT Number: NCT02201511

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

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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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Clinical Research Unit

Brussels, B-1070, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3 mg PF-06412562 MR tablets_Fasted

Drug

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

2 x 15 mg PF-06412562 MR tablets_Fasted

Drug

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

2 x 15 mg PF-06412562 MR tablets_Fed

Drug

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

10 mg PF-06412562 IR tablets

Drug

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

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax)

    Time frame: 0-2 days

  2. Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Time frame: 0-2 days

  3. Time after dose and before the first plasma concentration (Tlag)

    Time frame: 0-2

  4. Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf]

    Time frame: 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).

  5. Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]

    Time frame: 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)

  6. Plasma Decay Half-Life (t1/2)

    Time frame: 0-2 days

    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jul 28, 2014
Registry last updated
Nov 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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