Relative Bioavailability of Binimetinib 3 x 15 mg and 45 mg Formulations
Status:
Active, not recruiting
Trial end date:
2021-11-29
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 relative bioavailability of the 45 mg tablet in comparison to
three 15 mg tablets intake is therefore required.