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A Study To Investigate The Taste Of Crizotinib Liquid In Trained Healthy Adult Volunteers

Last updated on May 10, 2018

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Study Location
Pfizer Investigational Site
Woburn, Massachusetts, 01801 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01125904
Pfizer
Completed
A Study To Investigate The Taste Of Crizotinib Liquid In Trained Healthy Adult Volunteers

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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
An oral-liquid, pediatric form of crizotinib designed for use by pediatric patients is being tested for its' palatability in adults.
Taste assessment of new formulation. Subjects will not ingest the drug.
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Healthy
Drug: crizotinib
Oral liquid. Taste assessment of new formulation. Subjects will not ingest the drug.
Experimental: crizotinib
Intervention: Drug: crizotinib
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5
June 2010
June 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01125904
A8081018
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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