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Pharmacokinetics of Perampanel in Healthy Korean, White, and Japanese Adult Subjects

Perampanel is a highly selective, orally active, noncompetitive α‐amino‐3‐hydroxy‐5‐methyl‐4‐isoxazolepropionic acid receptor antagonist that has been approved in many countries as a treatment for partial‐onset seizures and primary generalized tonic‐clonic seizures. The pharmacokinetics (PK) of perampanel following multiple doses in healthy Korean, white, and Japanese male subjects were assessed in 3 studies. Noncompartmental PK parameters were derived from plasma concentration‐time data. At steady state of perampanel 2‐, 4‐, and 6‐mg oral multiple administration, perampanel was rapidly absorbed, as plasma perampanel concentration reached maximum concentration after 0.55–1 hour (median) after dosing in all 3 ethnic groups. The elimination was slow, with terminal elimination phase half‐life values ranging from 63.9–129 hours (mean) for doses of 2–6 mg; there was no specific tendency suggesting a dose‐related effect, and perampanel PK were linear in Korean subjects. There were no clinically relevant ethnic differences in PK following multiple doses of perampanel 2 and 4 mg between Korean, white, or Japanese subjects. Perampanel was well tolerated by all 3 ethnic groups. This outcome indicates that with respect to PK, the dosing regimens established in white and Japanese patients are applicable to Korean patients.