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Regorafenib; Regorafenib plus ketoconazole · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Arm1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Regorafenib (BAY73-4506); Regorafenib (BAY73-4506) plus ketoconazole | DRUG | 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. |
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...
Regorafenib is a small molecule drug developed by Bayer AG under the code BAY73-4506. It has been studied in a Phase 1 pharmacokinetics trial, and it is also being evaluated in combination with ketoconazole. The specific disease indications studied for this asset have not been disclosed.
Regorafenib is developed by Bayer AG, which trades on the OTC market under the ticker BAYRY. The compound is also known by the research code BAY73-4506. Bayer conducted the clinical work evaluating regorafenib alone and regorafenib plus ketoconazole.
Regorafenib is in Phase 1 development for this program. One Phase 1 trial has been completed, and no trials are currently active. The completed study enrolled 24 healthy male volunteers and examined the effect of ketoconazole on regorafenib pharmacokinetics.
Regorafenib has been studied in one completed Phase 1 trial, NCT01318265, titled Effect of Ketoconazole on Regorafenib (BAY73-4506) Pharmacokinetics. The trial enrolled 24 healthy male volunteers aged 18 years and older in the United States and used an uncontrolled design without randomization or blinding.
Yes. Regorafenib is also known as BAY73-4506, its internal research code. The combination studied in the clinic, regorafenib plus ketoconazole, is likewise referred to as BAY73-4506 plus ketoconazole. Both names refer to the same Bayer AG compound.
The completed Phase 1 trial NCT01318265 evaluated how ketoconazole affects the pharmacokinetics of regorafenib, also called BAY73-4506. It enrolled 24 healthy male volunteers in the United States in an uncontrolled, non-randomized, non-blinded design. The trial is listed as completed, and no further trials are currently active.