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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: crizotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01125904

A8081018

Details and patient eligibility

About

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

Full description

Taste assessment of new formulation. Subjects will not ingest the drug.

Enrollment: 5 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

5 participants in 1 patient group

crizotinib

Experimental group

Treatment:

Drug: crizotinib