What question did this study set out to answer?

This research aims to compare the pharmacokinetics and safety of votoplam in Caucasian and Japanese subjects.

May 2, 20260 citations

Ethnic Bridging of Votoplam, a HTT Gene Splicing Modifier, Using Pharmacokinetic Comparison Between Caucasian and Japanese Subjects.

LLLucy Lee ARAmy-Lee Richards PAPrachi Anand

Key Points

This research aims to compare the pharmacokinetics and safety of votoplam in Caucasian and Japanese subjects.
Conducted a pharmacokinetic analysis comparing healthy Caucasian and Japanese participants.
Administered single doses of votoplam at 5, 10, and 20 mg.
Monitored adverse events and dose proportionality across both ethnicities.
Pharmacokinetics increased by 1.58-, 1.19-, and 1.61-fold for 5, 10, and 20 mg, respectively, in Japanese compared to Caucasians.
Similar safety profiles were observed with few mild and moderate adverse events reported.
No dose adjustments are necessary for future studies involving Japanese participants.

Abstract

increased by 1.58-, 1.19-, and 1.61-fold for 5, 10, and 20 mg, respectively, for Japanese compared with Caucasian participants. Doses proportionality was observed for both ethnicities. Few mild and moderate TEAEs were reported and were comparable between Japanese and Caucasian participants. In summary, votoplam pharmacokinetics and safety profiles are similar between healthy Japanese and Caucasian participants when administered in the single dose range of 5, 10, and 20 mg. Therefore, it is expected that dose adjustments should not be necessary in future clinical studies enrolling Japanese participants.

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