Bioequivalence And Food Effect Study Of Bosutinib In Heal... | NCT01374139

Studies
Bioequivalence And Food Effect Study Of Bosutinib In Healthy Subjects

NCT01374139

Sponsor

Pfizer

Status

Completed

Last Update Posted

Nov 30, 2011Estimated

Enrollment

88Actual

Phase

Phase 1

Conditions

Philadelphia Chromosome Positive (Ph+) Chronic Myeloid Leukemia (CML)

Interventions

Bosutinib
Bosutinib

Countries

Singapore

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

Nov 2011

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

Aug 2011

Primary Completion Date

Oct 2011Actual

Completion Date

Oct 2011Actual

First Submitted Date

Jun 7, 2011

First Submission Date that Met QC Criteria

Jun 14, 2011

First Posted Date

Jun 15, 2011Estimated

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

Nov 28, 2011

Last Update Posted Date

Nov 30, 2011Estimated

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

Description Module

Brief Summary

The purpose of this study is to demonstrate the bioequivalence of the clinical tablet formulation (100 mg x 5) to the clinical capsule formulation (100 mg x 5) in healthy subjects under fed condition (Cohort 1) and to investigate the effect of a high-fat meal on the pharmacokinetics of bosutinib after administration of the proposed commercial tablet formulation (100 mg x 4) in healthy subjects (Cohort 2).

Detailed Description

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

88Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort 1	Experimental		Drug: Bosutinib
Cohort 2	Experimental		Drug: Bosutinib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bosutinib	Drug	5 clinical 100 mg tablets and 100 mg capsules, 500 mg, single dose, 2x2 crossover under fed condition	Cohort 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Plasma Cmax for bosutinib.		96 hr post dose in each period
AUCt for bosutinib.		96 hr post dose in each period
Plasma AUCinf for bosutinib.		96 hr post dose in each period
AUClast for bosutinib.		96 hr post dose in each period
Tmax for bosutinib.		96 hr post dose in each period
t½ for bosutinib.		96 hr post dose in each period

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 21 and 55 years, inclusive.
Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 Lead ECG or clinical laboratory tests.

Exclusion Criteria:

Pregnant or nursing women or women of childbearing potential.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Singapore		188770	Singapore

References Module

Citations

Not provided

ID	Term
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms