NCT01002378

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

October 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 27, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

May 23, 2013

Status Verified

May 1, 2013

Enrollment Period

4 months

First QC Date

October 26, 2009

Last Update Submit

May 21, 2013

Conditions

Dietary FatsPharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • Primary PK parameters: AUC, Cmax of BAY 73-4506

    Samples up to 336 hours post dose

Secondary Outcomes (2)

  • 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

Study Arms (3)

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

Regorafenib (Stivarga, BAY73-4506)DRUG

A single dose of regorafenib will be administered immediately following a high fat breakfast

Arm 1

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Brighton, Massachusetts, 02135, United States

Location

MeSH Terms

Interventions

regorafenib

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 26, 2009

First Posted

October 27, 2009

Study Start

October 1, 2009

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

May 23, 2013

Record last verified: 2013-05

Locations

US(1)