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BAY86-9766 · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| BAY86-9766 | EXPERIMENTAL | The study will be conducted in two parts and study treatments will be administered as follows: •Part A: Three subjects will be enrolled and will receive 10 mg of refametinib on Day 1. Once daily dosing of ketoconazole 400 mg will be initiated on Day 5 and will continue until Day 12 with 10 mg of refametinib administered concomitantly on Day 8 •Part B: Fifteen subjects will be enrolled and will receive refametinib doses of 10 mg, 20 mg or 30 mg on Days 1 and 8 with the same dose administered on both days. Refametinib dose for Part B will be based on safety and refametinib pharmacokinetics in Part A. Ketoconazole 400 mg will be administered once daily on Days 5 to 12. Subjects will stay in the investigational site for a total period of 15 consecutive days |
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | EXPERIMENTAL | - |
| Arm 3 | EXPERIMENTAL | - |
| Arm 4 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| BAY86-9766 | DRUG | - |
| Ketoconazole | DRUG | - |
Inclusion Criteria: * Healthy male subject * Age: 18 to 45 years (inclusive) at the first screening examination / visit * Body mass index (BMI): 18.5 to 32 kg/m² (inclusive) * Ability to understand and follow study-related instructions. Subject, who is a sexually active man and has not been surgica...
BAY86-9766 is an investigational small molecule being studied for use in neoplasms, pancreatic neoplasms, and drug interactions. It has been evaluated in Phase 1 clinical trials, including as a monotherapy in Japanese patients with neoplasms and in combination with gemcitabine for advanced pancreatic cancer.
BAY86-9766 is a small molecule developed by Bayer AG. Its specific molecular target has not been disclosed in the available clinical trial information. The drug is being investigated for its potential effects in treating certain cancers, including pancreatic cancer.
BAY86-9766 is being developed by Bayer AG, a multinational pharmaceutical company. Bayer AG is publicly traded under the ticker symbol BAYRY on the OTC market. The drug is currently in Phase 1 clinical development.
BAY86-9766 is in Phase 1 clinical development. All three clinical trials associated with the drug have been completed, with no active trials currently ongoing. The drug remains investigational and has not been approved by regulatory authorities.
BAY86-9766 has been studied in three completed Phase 1 trials: NCT01179295, a monotherapy study in Japanese patients with neoplasms; NCT01251640, a combination study with gemcitabine in advanced pancreatic cancer; and NCT01925638, a drug interaction study with ketoconazole in healthy male volunteers.
Yes, BAY86-9766 is also known as refametinib. The drug interaction trial NCT01925638 is titled 'Effect of Ketoconazole on the Pharmacokinetics of Refametinib,' confirming that refametinib is an alternative name for BAY86-9766.