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

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

Summary

An oral-liquid, pediatric form of crizotinib designed for use by pediatric patients is being tested for its' palatability in adults.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pfizer
• Treatments: Crizotinib

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.