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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: crizotinib

• 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.

Study Timeline

• Study First Submitted: 2010-05-17
• Study First Submitted QC: 2010-05-17
• Study First Posted: 2010-05-19
• Study Start: 2010-06
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-21
• Last Update Posted: 2010-07-23

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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Woburn, Massachusetts, United States