A Study To Investigate The Taste Of Crizotinib Liquid In Trained Healthy Adult Volunteers
NCT01125904
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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.
- 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.
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Descriptive Information | ||||
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Brief Title ICMJE | A Study To Investigate The Taste Of Crizotinib Liquid In Trained Healthy Adult Volunteers | |||
Official Title ICMJE | A Study In Trained Taste Panel Healthy Adult Volunteers To Investigate The Palatability Of Select Formulations Of Crizotinib Oral Liquid | |||
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. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) | |||
Condition ICMJE | Healthy | |||
Intervention ICMJE | Drug: crizotinib
Oral liquid. Taste assessment of new formulation. Subjects will not ingest the drug. | |||
Study Arms ICMJE | Experimental: crizotinib
Intervention: Drug: crizotinib | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 5 | |||
Original Estimated Enrollment ICMJE | 7 | |||
Actual Study Completion Date ICMJE | June 2010 | |||
Actual Primary Completion Date | June 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01125904 | |||
Other Study ID Numbers ICMJE | A8081018 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | July 2010 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |