A Study To Investigate The Taste Of Crizotinib Liquid In... | NCT01125904

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

NCT01125904

Sponsor

Pfizer

Status

Completed

Last Update Posted

Jul 23, 2010Estimated

Enrollment

5Actual

Phase

Phase 1

Conditions

Healthy

Interventions

crizotinib

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2010

Primary Completion Date

Jun 2010Actual

Completion Date

Jun 2010Actual

First Submitted Date

May 17, 2010

First Submission Date that Met QC Criteria

May 17, 2010

First Posted Date

May 19, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 21, 2010

Last Update Posted Date

Jul 23, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Label	Type	Description	Intervention Names
crizotinib	Experimental		Drug: crizotinib

Name	Type	Description	Arm Group Labels	Other Names
crizotinib	Drug	Oral liquid. Taste assessment of new formulation. Subjects will not ingest the drug.	crizotinib

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Woburn	Massachusetts	01801	United States

Label	URL
To obtain contact information for a study center near you, click here.	View source

Intervention Browse Module

MeSH Terms

ID	Term
D000077547	Crizotinib

Ancestor Terms

ID	Term
D010880	Piperidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D000631	Aminopyridines

Browse Leaves

Not provided

Browse Branches

Not provided