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Regorafenib; Regorafenib plus ketoconazole

Phase 1

Pharmacokinetics | Small molecule | Other |Bayer AG|Last Updated: Nov 3, 2014

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

Regorafenib; Regorafenib plus ketoconazole · 1 trial · 1 indication

Phase 1 1
NCT01318265Effect of Ketoconazole on Regorafenib (BAY73-4506) PharmacokineticsPharmacokinetics
COMPLETED24 Analytics
PHASE1COMPLETED
Effect of Ketoconazole on Regorafenib (BAY73-4506) Pharmacokinetics
Pharmacokinetics
NCT0131826524
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Study Endpoints

Primary Endpoints

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 Endpoints

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
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelCROSSOVER

Treatment Arms

ArmTypeDescription
Arm1EXPERIMENTAL -

Interventions

NameTypeDescription
Regorafenib (BAY73-4506); Regorafenib (BAY73-4506) plus ketoconazoleDRUGTreatment 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.
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Eligibility Criteria

Age Range18 Years to 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

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 * Hi...

Countries:United States
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