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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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

Additional relevant MeSH terms:
Crizotinib
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on October 29, 2014