A Phase 1 Study to Investigate the Effects of Cortexolone 17α-Propionate, Also Known as Clascoterone, on the QT Interval Using the Meal Effect to Demonstrate ECG Assay Sensitivity
May 2021
in “
Clinical Pharmacology in Drug Development
”
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Studysummary This phase 1 study reported that after administering supratherapeutic doses of cortexolone 17α‐propionate, a topical antiandrogen intended for hair loss treatment, there was no effect on the QTc interval, indicating no measurable cardiac safety concerns in the concentration range tested.
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This Phase I study assessed the cardiac safety of cortexolone 17α-propionate (clascoterone), a topical drug for androgenetic alopecia (AGA) and acne, in 32 healthy volunteers. The study was randomized, double-blind, and placebo-controlled, with participants receiving supratherapeutic doses of the drug. The primary focus was on the QTc interval, which is critical for heart electrical activity. The study demonstrated that clascoterone does not cause QTc interval prolongation, even at high doses, as the upper end of the 2-sided 90% confidence interval for the change in QTcF was below 10 milliseconds. Assay sensitivity was confirmed using the meal effect on the QTc interval. All participants completed the study, with 12 mild adverse events reported in 9 participants, except for one moderate migraine case. The results indicate that clascoterone is safe for long-term use without medical supervision regarding cardiac effects.
