A Single- and Multiple-Dose Pharmacokinetic Study of Oral Perampanel in Healthy Chinese Subjects.

Background And Objective: Perampanel is a once-daily oral anti-seizure medication indicated for focal-onset seizures and generalized tonic-clonic seizures. This study investigated the single- and multiple-dose pharmacokinetics of perampanel in healthy Chinese adults.

Methods: Study 052 (NCT03424564) was a phase I, single-center, open-label, parallel-group study.

A phase I pharmacokinetic study of lenvatinib in Chinese patients with unresectable hepatocellular carcinoma.

This phase I study assessed the pharmacokinetic profile, safety and antitumor activity of lenvatinib in Chinese patients with unresectable hepatocellular carcinoma. Bodyweight-based lenvatinib dosing was administered (patients <60 kg: 8 mg/day, n = 13; patients ≥60 kg: 12 mg/day, n = 12). Pharmacokinetic sampling was performed during the first cycle.

Phase 1 study of tazemetostat in Japanese patients with relapsed or refractory B-cell lymphoma.

Background: Tazemetostat is a selective and orally available inhibitor of enhancer of zeste homolog 2 (EZH2), a histone methyltransferase and epigenetic regulator of cellular differentiation programs. We carried out a phase I study of tazemetostat in Japanese patients with relapsed or refractory B-cell non-Hodgkin-type lymphoma (B-NHL) to evaluate its tolerability, safety, pharmacokinetics, and preliminary antitumor activity.

Methods: Tazemetostat was given orally at a single dose of 800 mg on the first day and 800 mg twice daily (BID: total 1600 mg/d) on following days in a 28-day/cycle manner.

Pharmacokinetic study of lenvatinib in Chinese patients with solid tumors.

To assess the pharmacokinetics of once-daily oral lenvatinib 24 mg in Chinese patients. Patients had any solid tumor (except hepatocellular carcinoma) that was resistant to standard antitumor therapies or for which no appropriate treatment was available. Twelve patients were enrolled.

Bioequivalence of perampanel fine granules and tablets in healthy Japanese subjects.

Objective: Perampanel is an approved anti-seizure drug. A new formulation of perampanel fine granules (FG; 1% perampanel) has been developed for patients who are unable to take tablets. Bioequivalence between the 4-mg FG and tablet perampanel formulations, as well as their safety and tolerability, were assessed.

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.