At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Single-center, Open-label, Single Dose, Two-period, Crossover Pivotal Bioequivalence Study Comparing Binimetinib 3 x 15 mg and 45 mg Tablets in Healthy Participants
In Brief
A Phase 1 clinical trial evaluating Binimetinib 15 MG and Binimetinib 45 MG for Melanoma and 3 related conditions. Completed, enrolled 37 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Binimetinib 15 mg tablet
Binimetinib 45 mg tablet