The Effect of Food (High Fat and Low Fat Breakfast) on th... | NCT01002378

Studies
The Effect of Food (High Fat and Low Fat Breakfast) on the Pharmacokinetics of Regorafenib

NCT01002378

Sponsor

Bayer

Status

Completed

Last Update Posted

May 23, 2013Estimated

Enrollment

24Actual

Phase

Phase 1

Conditions

Dietary Fats
Pharmacokinetics

Interventions

Regorafenib (Stivarga, BAY73-4506)
Regorafenib (Stivarga, BAY73-4506)
Regorafenib (Stivarga, BAY73-4506)

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

May 2013

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

Oct 2009

Primary Completion Date

Feb 2010Actual

Completion Date

Feb 2010Actual

First Submitted Date

Oct 26, 2009

First Submission Date that Met QC Criteria

Oct 26, 2009

First Posted Date

Oct 27, 2009Estimated

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

May 21, 2013

Last Update Posted Date

May 23, 2013Estimated

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

An open label, three way crossover study to determine the effect of a high fat breakfast or a low fat breakfast on the pharmacokinetics of a single dose of regorafenib.

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

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Arm 1	Experimental	Drug: Regorafenib (Stivarga, BAY73-4506)
Arm 2	Experimental	Drug: Regorafenib (Stivarga, BAY73-4506)
Arm 3	Experimental	Drug: Regorafenib (Stivarga, BAY73-4506)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Regorafenib (Stivarga, BAY73-4506)	Drug	A single dose of regorafenib will be administered immediately following a high fat breakfast	Arm 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Primary PK parameters: AUC, Cmax of BAY 73-4506		Samples up to 336 hours post dose

Secondary Outcomes

Measure	Description	Time Frame
Sec. PK Parameters: tmax and t1/2 of BAY73-4506		Samples up to 336 hours post dose
AUC, Cmax, tmax and t1/2 of Metabolites		Samples up to 336 hours post dose

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy male subject
Age: 18 to 45 years (inclusive) at the first Screening examination
BMI: between 18 and 32 kg / m²

Exclusion Criteria:

Regular use of medicines at the time of Screening, including prescription medications, herbal supplements and high dose vitamins
Sitting systolic BP > 140 mmHg or Diastolic BP > 90 or < 60 mmHg
History of hypersensitivity or allergy
History of somatic or psychiatric disease/condition, which may interfere with the objectives of the study

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Brighton	Massachusetts	02135	United States

Intervention Browse Module

MeSH Terms

ID	Term
C559147	regorafenib

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided