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Journal of Pharmacognosy & Natural Products

Journal of Pharmacognosy & Natural Products

ISSN: 2472-0992

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Padsevonil (PSL; UCB0942) is a rationally designedinvestigational antiepileptic drug targeting SV2 proteins and GABAAreceptors. Pharmacokinetics (PK) of PSL in healthy Japanese and Cau-casian volunteers was evaluated using conventional venous samplingand novel microsampling technique (MITRA). Method: Individualswere randomized to PSL or placebo (PBO) (each cohort: 10 PSL/2PBO). Single dose (SD) cohorts: Japanese received PSL 50 mg(cohort‐1) or 100 mg (cohort‐2). Multiple dose (MD) cohorts: Japanese(cohort‐3) or Caucasians (cohort‐4) received single PSL 200 mg, thenafter maximum 21 days PSL 100 mg bid for 3.5 days. Blood for PKwas acquired using conventional venepuncture (plasma) andmicrosampling (MITRA, dried blood). Primary PK variables: CmaxandAUC. Results: Forty‐eight volunteers participated (mean age:32.8 years; 54.2% female); none discontinued. Mean weight waslower in Japanese than Caucasians (58 kg vs 72 kg). PK profilessupported dose proportionality for overall exposure in Japanese(Figure 1). AUC and Cmaxwere ~1.5 (SD) to 1.6 times (MD) higherin Japanese than Caucasians, driven by bodyweight differences(Table 1). No major differences in major metabolites observed. Com-parison of plasma (venous) and whole blood (MITRA) data were con-sistent with known whole blood/plasma partition (0.7). Safety

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Citations: 606

Journal of Pharmacognosy & Natural Products received 606 citations as per Google Scholar report

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