A trial to demonstrate that administration of binimetinib treatment using a 45 mg strength tablet is equivalent to 3 tablets of 15 mg.

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

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Status :
Type of study
Phase I
Min. Age
Years old
Max. Age
Years old

Brief summary

Binimitenib (MEKTOVI®) is a marketed drug for the treatment of adults' patients with unresectable or metastatic melanoma presenting a specific mutation (BRAF V600 mutation).

In order to facilitate treatment administration, a new strength tablet containing 45 mg of binimetinib is being developed. As a result, the number of binimetinib 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 purpose of the trial is to demonstrate the bioequivalence of the two formulations; it means that binimetinib treatment is delivered in the body in the same way (in quantity and speed) with a 45 mg-tablet than with 3 tablets of 15 mg.

Therapeutic area :
Disease :
Healthy volunteers
Study medication :
Binimetinib (MEKTOVI®)
Phase : Phase I
Start Date :
31 August 2022
End Date / Planned study Completion Date :
December 2022
Study ID : W00074CI103
EudraCT/CTIS number : 2022-000610-34
Countries :

Find out where the clinical trial is conducted



7-9 rue Jean Louis Bertrand CS 34246
35000 Rennes

Last update at : 15 November 2023

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