A Study To Investigate The Taste Of Crizotinib Liquid In Trained Healthy Adult Volunteers
- Registration Number
- NCT01125904
- Lead Sponsor
- Pfizer
- Brief Summary
An oral-liquid, pediatric form of crizotinib designed for use by pediatric patients is being tested for its' palatability in adults.
- Detailed Description
Taste assessment of new formulation. Subjects will not ingest the drug.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description crizotinib crizotinib -
- Primary Outcome Measures
Name Time Method A complete description of the sensory attributes of drug product prototype formulations (eg, aroma, flavor, texture, and mouthfeel). 2 months
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie crizotinib's taste profile in oral liquid formulations for pediatric use?
How does the palatability of crizotinib oral liquid compare to standard-of-care liquid chemotherapies in taste trials?
Are there specific biomarkers associated with improved palatability of tyrosine kinase inhibitors in healthy volunteers?
What adverse events are commonly reported with crizotinib formulations and how are they managed in clinical practice?
How do Pfizer's crizotinib liquid formulations compare to other ALK inhibitor oral solutions in terms of taste and patient compliance?
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Woburn, Massachusetts, United States
Pfizer Investigational Site🇺🇸Woburn, Massachusetts, United States