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
1 other identifier
interventional
5
1 country
1
Brief Summary
An oral-liquid, pediatric form of crizotinib designed for use by pediatric patients is being tested for its' palatability in adults.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started Jun 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2010
CompletedFirst Posted
Study publicly available on registry
May 19, 2010
CompletedStudy Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedJuly 23, 2010
July 1, 2010
Same day
May 17, 2010
July 21, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
A complete description of the sensory attributes of drug product prototype formulations (eg, aroma, flavor, texture, and mouthfeel).
2 months
Study Arms (1)
crizotinib
EXPERIMENTALInterventions
Oral liquid. Taste assessment of new formulation. Subjects will not ingest the drug.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Investigational Site
Woburn, Massachusetts, 01801, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 17, 2010
First Posted
May 19, 2010
Study Start
June 1, 2010
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
July 23, 2010
Record last verified: 2010-07