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Effect of Ketoconazole on Regorafenib (BAY73-4506) Pharmacokinetics

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ClinicalTrials.gov Identifier: NCT01318265
Recruitment Status : Completed
First Posted : March 18, 2011
Last Update Posted : November 3, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

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.

Condition or disease Intervention/treatment Phase
Pharmacokinetics Drug: Regorafenib (BAY73-4506); Regorafenib (BAY73-4506) plus ketoconazole Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: 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
Study Start Date : March 2011
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm1 Drug: Regorafenib (BAY73-4506); Regorafenib (BAY73-4506) plus ketoconazole
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.




Primary Outcome Measures :
  1. Area under the plasma concentration versus time curve from zero to infinity ( Plasma AUCinf) of BAY73-4506 given alone or with ketoconazole. [ Time Frame: 1 month ]
  2. Peak plasma concentration (Cmax) of BAY73-4506 given alone or with ketoconazole [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Plasma AUCinf of metabolites of a single oral dose BAY73-4506 given alone or with ketoconazole. [ Time Frame: 1 month ]
  2. Plasma Cmax of metabolites of a single oral dose BAY73-4506 given alone or with ketoconazole. [ Time Frame: 1 month ]
  3. Number of subjects with adverse events following a single oral dose of BAY73-4506, adminstered alone and concomitantly with ketoconazole. [ Time Frame: 1 month ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01318265


Locations
United States, Massachusetts
Brighton, Massachusetts, United States, 02135
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01318265     History of Changes
Other Study ID Numbers: 12435
First Posted: March 18, 2011    Key Record Dates
Last Update Posted: November 3, 2014
Last Verified: October 2014

Keywords provided by Bayer:
drug interactions
ketoconazole
pharmacokinetics
human volunteers

Additional relevant MeSH terms:
Ketoconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors