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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01125904
First received: May 17, 2010
Last updated: July 21, 2010
Last verified: July 2010
History of Changes

May 17, 2010
July 21, 2010
June 2010
June 2010   (final data collection date for primary outcome measure)
A complete description of the sensory attributes of drug product prototype formulations (eg, aroma, flavor, texture, and mouthfeel). [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01125904 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Study To Investigate The Taste Of Crizotinib Liquid In Trained Healthy Adult Volunteers
A Study In Trained Taste Panel Healthy Adult Volunteers To Investigate The Palatability Of Select Formulations Of Crizotinib Oral Liquid

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

Taste assessment of new formulation. Subjects will not ingest the drug.
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Healthy
Drug: crizotinib
Oral liquid. Taste assessment of new formulation. Subjects will not ingest the drug.
Experimental: crizotinib
Intervention: Drug: crizotinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5
June 2010
June 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01125904
A8081018
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP