Effect of Ketoconazole on Regorafenib (BAY73-4506) Pharmacokinetics

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01318265

Enrollment

Registered

2011-03-18

Start date

2011-03-31

Completion date

2011-07-31

Last updated

2014-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pharmacokinetics

Keywords

drug interactions, ketoconazole, pharmacokinetics, human volunteers

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.

Interventions

DRUGRegorafenib (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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026