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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01125904

Enrollment

Registered

2010-05-19

Start date

2010-06-30

Completion date

2010-06-30

Last updated

2010-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Crizotinib

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.

Interventions

DRUGcrizotinib

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
A complete description of the sensory attributes of drug product prototype formulations (eg, aroma, flavor, texture, and mouthfeel).	2 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026