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Completed

NCT Number: NCT01125904

A Study To Investigate The Taste Of Crizotinib Liquid In Trained Healthy Adult Volunteers

An oral-liquid, pediatric form of crizotinib designed for use by pediatric patients is being tested for its' palatability in adults.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Woburn, Massachusetts, 01801, United States

About this study

Taste assessment of new formulation. Subjects will not ingest the drug.

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 of non childbearing potential subjects between the ages of 18 and 75 years, inclusive.
  • Subjects must be trained sensory panelists.
  • An informed consent document signed and dated by the subject or a legally acceptable representative.
  • Subjects who are willing and able to comply with scheduled visits, product evaluations, laboratory tests, and other study procedures.

Exclusion criteria

  • A history of clinically significant hematological, renal, endocrine, pulmonary , glaucoma, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, allergic disease (excluding untreated, asymptomatic seasonal allergies at the time of product evaluation) as evaluated through a medical history.
  • A history of hypersensitivity to any inactive ingredients employed in the formulation(s).
  • Receiving treatment with an investigational drug within 28 days preceding any of the product evaluations for this study.
  • Participation in a product taste evaluation (ie, 'sip and spit' type taste evaluation) involving an active pharmaceutical ingredient (API) within 5 half lives of that API.
  • Unwilling or unable to comply with the Lifestyle guidelines described in this protocol.

Treatment and study plan

Crizotinib

Drug

Oral liquid. Taste assessment of new formulation. Subjects will not ingest the drug.

Primary outcomes

  1. A complete description of the sensory attributes of drug product prototype formulations (eg, aroma, flavor, texture, and mouthfeel).

    Time frame: 2 months

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Study In Trained Taste Panel Healthy Adult Volunteers To Investigate The Palatability Of Select Formulations Of Crizotinib Oral Liquid

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
May 19, 2010
Registry last updated
Jul 23, 2010

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.

Published trials that share one or more normalized conditions with this study.