期刊
CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT
卷 8, 期 2, 页码 172-178出版社
WILEY
DOI: 10.1002/cpdd.645
关键词
ataluren; Duchenne muscular dystrophy; nonsense mutations; pharmacokinetics; phase 1; ethnicity
资金
- PTC Therapeutics, Inc.
To evaluate the potential for ethnicity-related differences in ataluren pharmacokinetics (PK) and safety, a phase 1 single-dose study was conducted in 48healthy (24 Japanese and 24 Caucasian subjects), nonsmoking male volunteers who were equally divided into 3cohorts of oral doses at 5, 10, and 20 mg/kg. Blood samples were collected until 48 hours postdose. PK results demonstrated rapid absorption of ataluren, with peak plasma levels (C-max) being attained between 0.875and 2.5 hours after dosing. The mean C-max and area under the concentration-time curve (AUC((0-last))) increased with each increasing dose level in both Japanese and Caucasian subjects. Although the C-max was similar across all subjects at each dose regardless of ethnicity, Japanese subjects had a mean AUC((0-last)) approximately 14% to 34% lower than that of Caucasian subjects across the 3 dose levels. This difference was likely due to the higher variability of AUC values in Caucasian subjects and the relatively small study population. In conclusion, similar ataluren PK profiles were observed in healthy Japanese and Caucasian subjects following single oral administration of ataluren at all dose levels.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据