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Completed

NCT Number: NCT02006277

A Study To Taste Three New Types Of Crizotinib Formulation In Comparison Of An Oral Solution And To Measure The Amount Of Crizotinib In The Body After These Formulations Are Orally Given, Relative To Capsule Formulation

This study is intended to evaluate the sensory attributes and estimate the relative bioavailability of three prototype oral formulations. Subjects will either taste 75-mg doses by "swirl and spit" (Cohort 1) or will receive five oral single 250-mg doses with a washout period of at least 14 days (Cohort 2).

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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 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 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 or clinical laboratory tests.
  • Female subjects of non child bearing potential must have a 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).
  • Pregnant or nursing females; females of childbearing potential.
  • Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study medication. Limited use of non prescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case-by-case basis following approval by the sponsor.

Treatment and study plan

Crizotinib prototype microsphere 0.529 mg/mg

Drug

Subjects will take each sample into their mouths, swirl the sample for approximately 30 seconds, and then expectorate into an empty cup.

crizotinib prototype microsphere 0.470 mg/mg

Drug

Subjects will take each sample into their mouths, swirl the sample for approximately 30 seconds, and then expectorate into an empty cup.

crizotinib prototype microsphere 0.420 mg/mg

Drug

Subjects will take each sample into their mouths, swirl the sample for approximately 30 seconds, and then expectorate into an empty cup.

crizotinib oral solution

Drug

Subjects will take each sample into their mouths, swirl the sample for approximately 30 seconds, and then expectorate into an empty cup.

crizotinib capsule

Drug

Subjects will receive a single 250-mg oral dose of crizotinib.

Primary outcomes

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

    Time frame: 3 months

    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).

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

    Time frame: 3 months

    AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)

  3. Maximum Observed Plasma Concentration (Cmax)

    Time frame: 3 months

  4. Overall liking, mouth feel, bitterness, tongue/mouth burn of sensory attributes and formulation preference for Cohort 1

    Time frame: 3 months

Secondary outcomes

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

    Time frame: 3 months

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

    Time frame: 3 months

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

  3. Apparent Oral Clearance (CL/F)

    Time frame: 3 months

    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.

  4. Apparent Volume of Distribution (Vz/F)

    Time frame: 3 months

    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

  5. Overall liking, bitterness, mouth feel, tongue/mouth burn, throat burn of sensory attributes for Cohort 2.

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 1, Open-label, Crossover Taste And Pharmacokinetic Study In Healthy Adult Volunteers To Evaluate The Palatability And Estimate The Bioavailability Of Three Prototype Formulations Of Crizotinib

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 10, 2013
Registry last updated
Apr 14, 2014

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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