Cardiomegaly Clinical Trial
Official title:
An Open Label Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MEK162 in Noonan Syndrome Hypertrophic Cardiomyopathy
The purpose of the study is to determine whether the ability of MEK162 to antagonize MEK activation in NS HCM patients, who usually have upstream mutations in the Ras-Raf-Mek-Erk pathway that lead to MEK activation, would be beneficial over a 6 month treatment period in hypertrophy regression.
This study is designed as a proof of concept of MEK162 in NS HCM patients. The purpose of the
present study is to determine whether the ability of MEK162 to antagonize MEK activation in
NS HCM patients, who usually have upstream mutations in the Ras-Raf-Mek-Erk pathway that lead
to MEK activation, would be beneficial over a 6 month treatment period by causing hypertrophy
regression. Such regression might result in cardiovascular clinical benefits with longer term
treatment.
The information gained from this study will be three fold:
1. the safety/tolerability of treatment with MEK162 over 6 month in the NS HCM patient
population
2. the pharmacokinetics and pharmacodynamics of MEK162 in the target patient population
3. proof of the therapeutic concept that MEK inhibition will reduce cardiac hypertrophy in
the target NS HCM patient population
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