check_circleStudy Completed

Pharmacokinetics

Bayer Identifier:

12435

ClinicalTrials.gov Identifier:

NCT01318265

EudraCT Number:

Not Available

EU CT Number:

Not Available
Effect of Ketoconazole on Regorafenib (BAY73-4506) pharmacokinetics

Trial purpose

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.

Key Participants Requirements

Sex

Male

Age

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

Trial summary

Enrollment Goal
24
Trial Dates
March 2011 - July 2011
Phase
Phase 1
Could I Receive a placebo
No
Products
Stivarga (Regorafenib, BAY73-4506)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
ProMedica Clincal Research CenterBrighton, 02135, United States

Primary Outcome

  • Area under the plasma concentration versus time curve from zero to infinity ( Plasma AUCinf) of BAY73-4506 given alone or with ketoconazole.
    date_rangeTime Frame:
    1 month
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    Safety Issue:
    No
  • Peak plasma concentration (Cmax) of BAY73-4506 given alone or with ketoconazole
    date_rangeTime Frame:
    1 month
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Plasma AUCinf of metabolites of a single oral dose BAY73-4506 given alone or with ketoconazole.
    date_rangeTime Frame:
    1 month
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    Safety Issue:
    No
  • Plasma Cmax of metabolites of a single oral dose BAY73-4506 given alone or with ketoconazole.
    date_rangeTime Frame:
    1 month
    enhanced_encryption
    Safety Issue:
    No
  • Number of subjects with adverse events following a single oral dose of BAY73-4506, adminstered alone and concomitantly with ketoconazole.
    date_rangeTime Frame:
    1 month
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

A Phase I, Non-Randomized, Open Label Study to Determine the Effetc of Ketoconazole on the Pharmacokinetics of a Single Oral Dose of Regorafenib (BAY73-4506) in Healthy Volunteers
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Non-randomized
Blinding
Open Label
Assignment
Crossover Assignment
Trial Arms
1

Additional Information

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