NCT01318265

Brief Summary

The purpose of this study is to estimate the effect of multiple doses of ketoconazole on the pharmacokinetics of a single dose of BAY73-4506 in healthy male volunteers.

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 Mar 2011

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

First Submitted

Initial submission to the registry

February 18, 2011

Completed
11 days until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 18, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

November 3, 2014

Status Verified

October 1, 2014

Enrollment Period

4 months

First QC Date

February 18, 2011

Last Update Submit

October 31, 2014

Conditions

Pharmacokinetics

Keywords

drug interactionsketoconazolepharmacokineticshuman volunteers

Outcome Measures

Primary Outcomes (2)

  • Area under the plasma concentration versus time curve from zero to infinity ( Plasma AUCinf) of BAY73-4506 given alone or with ketoconazole.

    1 month

  • Peak plasma concentration (Cmax) of BAY73-4506 given alone or with ketoconazole

    1 month

Secondary Outcomes (3)

  • Plasma AUCinf of metabolites of a single oral dose BAY73-4506 given alone or with ketoconazole.

    1 month

  • Plasma Cmax of metabolites of a single oral dose BAY73-4506 given alone or with ketoconazole.

    1 month

  • Number of subjects with adverse events following a single oral dose of BAY73-4506, adminstered alone and concomitantly with ketoconazole.

    1 month

Study Arms (1)

Arm1

EXPERIMENTAL
Drug: Regorafenib (BAY73-4506); Regorafenib (BAY73-4506) plus ketoconazole

Interventions

Regorafenib (BAY73-4506); Regorafenib (BAY73-4506) plus ketoconazoleDRUG

Treatment 1: A single 160 mg dose of BAY73-4506. Treatment 2: Ketoconazole 400 mg once daily from Day -4 to Day 3. A single 160 mg dose of BAY73-4506 on Day 1.

Arm1

Eligibility Criteria

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

You may qualify if:

  • Healthy male subjects between 18 and 45 years of age, inclusive
  • BMI between 18 and 32 kg/m2 inclusive

You may not qualify if:

  • Subjects with evidence of disease, conditions affecting drug absorption or metabolism
  • Treatment with other investigational drug within 30 days
  • History of regular alcohol or recreational drug consumption
  • Use of prescription drugs within 14 days
  • Use of nonprescription drugs and dietary supplement within 7 days
  • Blood donation within 30 days

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
NON RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2011

First Posted

March 18, 2011

Study Start

March 1, 2011

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

November 3, 2014

Record last verified: 2014-10

Locations

US(1)