Bioequivalence Binimetinib 3 x 15 mg and 45 mg Formulations
Status:
Completed
Trial end date:
2023-01-18
Target enrollment:
Participant gender:
Summary
The current commercially available MEKTOVI® (binimetinib) 15 mg tablets are provided as
immediate release film-coated tablets for oral administration. For the treatment of adult
patients with unresectable or metastatic melanoma with BRAF V600 mutation, the recommended
dosing regimen is 45 mg twice daily (bis in die, BID). No food effect with the commercial
formulation of 15 mg was demonstrated. In order to reduce the patient's burden, a new
strength tablet containing 45 mg of binimetinib as active ingredient is being developed. As a
result, the number of tablets to be taken by the patients will be reduced from 6 tablets (6 x
15 mg) to 2 tablets (2 x 45 mg) per day. The evaluation of the bioequivalence between one 45
mg tablet and three 15 mg tablets is therefore required.