The Effect of Itraconazole on the Pharmacokinetics of ACT-1004-1239
Key Findings:
CYP3A4 is an important enzyme in drug metabolism and interactions. ACT-1004-1239 is a promising treatment for demyelinating diseases and is mainly metabolized by CYP3A4. This study looked at how the strong CYP3A4 inhibitor itraconazole affected the pharmacokinetics of ACT-1004-1239 in healthy male subjects.
The study found that itraconazole led to a 2- to 3-fold increase in the exposure of ACT-1004-1239 in the body. Both treatments were well-tolerated, with similar rates of reported adverse events such as headache and nausea.
Conclusion:
ACT-1004-1239 is considered a moderately sensitive CYP3A4 substrate, and this should be taken into account in future clinical studies when CYP3A4 inhibitors are used alongside it.
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