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Completed

NCT Number: NCT01702506

Evaluation Of The Potential Effect That The Administration Of Food Or Antacid Medication May Have In The Oral Absorption Of Dacomitinib (PF-00299804)

Evaluation of the potential effect that the administration of food or antacid medication may have in the oral absorption of dacomitinib relative to the administration of dacomitinib in absence of food or antacid medication

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Key information

Conditions

Healthy Volunteers Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyslipidemias Genetic Diseases, Inborn Hypoalphalipoproteinemias Hypolipoproteinemias Lecithin Cholesterol Acyltransferase Deficiency Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

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 subjects including males between the ages of 18 and 55 years. Females of non childbearing potential .
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
  • An informed consent document signed and dated by the subject.

Exclusion criteria

  • Any condition possibly affecting drug absorption (eg, gastrectomy).
  • A positive urine drug screen.
  • Treatment with an investigational drug within 30 days (or as determined by the local requirement) or the appropriate time based on the elimination characteristics of the study medication.

Treatment and study plan

dacomitinib fasted

Drug

Overnight fasted subjects will receive a single 45 mg dose of dacomitinib

dacomitinib fed

Drug

Subjects will receive a single 45 mg dose of dacomitinib with a high calorie high fat meal

dacomitinib+antacid

Drug

Subjects will receive a single 45 mg dose of dacomitinib when there are treated with rabeprazole

Primary outcomes

  1. Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]

    Time frame: 2 weeks

    AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8). For dacomitinib and PF-05199265

  2. Maximum Observed Plasma Concentration (Cmax)

    Time frame: 2 weeks

    For dacomitinib and PF-05199265

Secondary outcomes

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

    Time frame: 2 weeks

    AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t).For dacomitinib and PF-05199265

  2. Area under the Concentration-Time Curve (AUC)

    Time frame: 3 days

    AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. For dacomitinib and PF-05199265

  3. Apparent Oral Clearance (CL/F)

    Time frame: 2 weeks

    Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. For dacomitinib

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

    Time frame: 2 weeks

    For dacomitinib and PF-05199265

  5. Apparent Volume of Distribution (Vz/F)

    Time frame: 2 weeks

    Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed. For dacomitinib

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

    Time frame: 2 weeks

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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Phase 1 Three Period Crossover Study To Evaluate The Effect Of Food And Antacids On The Pharmacokinetics, Safety & Tolerability Of PF-299,804 In Healthy Volunteers Who Have Received PF-299,804

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 8, 2012
Registry last updated
Dec 18, 2013

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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