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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
  Purpose

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


Condition Intervention Phase
Healthy
 Drug: crizotinib
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Study In Trained Taste Panel Healthy Adult Volunteers To Investigate The Palatability Of Select Formulations Of Crizotinib Oral Liquid

Resource links provided by NLM:

Drug Information available for: Crizotinib
U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Enrollment: 5
Study Start Date: June 2010
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: crizotinib Drug: crizotinib
Oral liquid. Taste assessment of new formulation. Subjects will not ingest the drug.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01125904

Locations
United States, Massachusetts
Pfizer Investigational Site
Woburn, Massachusetts, United States, 01801
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01125904     History of Changes
Other Study ID Numbers: A8081018
Study First Received: May 17, 2010
Last Updated: July 21, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Crizotinib

ClinicalTrials.gov processed this record on May 16, 2013