| セッション情報 | ポスターセッション(肝臓学会)C型肝炎-治療15 |
|---|---|
| タイトル | 肝P-301：Effect of food on the pharmacokinetics of simeprevir 100 mg; a single-dose, open-label, randomized, two-period crossover study in Japanese healthy adult male subjects |
| 演者 | 太田 建太郎（ヤンセンファーマ（株）・研究開発本部） |
| 共同演者 | 後藤 章一郎（ヤンセンファーマ（株）・研究開発本部） |
| 抄録 | BACKGROUND: Simeprevir is a potent and selective inhibitor of the HCV NS3/4A protease, a specific anti-hepatitis C virus (HCV) drug candidate. The primary objective of the study was to evaluate the effect of food on the plasma simeprevir pharmacokinetics in Japanese healthy adult subject using the gelatine capsule which contains simeprevir 100 mg as a sodium salt. METHOD: The study was conducted as a single-dose, open-label, randomized, two-period crossover study. Twenty-four Japanese healthy adult male subjects received a single dose of simeprevir 100 mg under either fed (standardized Japanese breakfast) or fasted conditions. The drug administrations were separated by a wash-out period of nine days. Plasma samples were collected for up to 72 hours. The food effect was evaluated using the geometric mean ratios (fed/fasted) of the primary parameters (Cmax and AUC∞) RESULTS: After administrations of simeprevir 100 mg under fed and fasted conditions, maximum plasma Simeprevir concentrations (1076- and 1020-ng/mL, respectively) were observed at a median of 6 hours after administrations under both conditions. Mean AUC∞ values were 11926- and 10633 ng.h/mL, respectively. Geometric mean ratios (90% confidence interval) for Cmax and AUC∞ were 1.018 (0.869-1.192) and 0.968 (0.841-1.115), respectively. CONCLUSION: The study demonstrated that there was no clinically significant effect of food on the plasma simeprevir pharmacokinetics after administration of simeprevir 100 mg as the gelatin capsule to Japanese healthy adult male subjects. |
| 索引用語 | simeprevir, 食事 |