Abstract:
INTRODUCTION:The pharmacokinetics, safety, and tolerability of DS-8500a (a G protein receptor 119 agonist) up to 100 mg have been investigated in healthy Japanese adults. The objective of this study was to evaluate the effects of hepatic or renal impairment on the pharmacokinetics of a single 25-mg oral dose of DS-8500a. METHODS:This single-center, open-label study enrolled subjects into eight groups according to hepatic function (normal; mild or moderate impairment) and renal function [normal; mild, moderate, or severe impairment; and end-stage renal disease (ESRD)]. Drug concentrations were measured by liquid-chromatography tandem mass spectrometry. Pharmacokinetic parameters were evaluated by non-compartmental analysis. Adverse events (AEs) were evaluated for safety. RESULTS:The hepatic and renal groups enrolled 15 and 30 subjects, respectively. Pharmacokinetic parameters of DS-8500a were comparable between the normal hepatic function and mild hepatic impairment groups, but the mean area under the concentration-time curve (AUC) was 1.37-fold higher, and the half-life was longer in the moderate hepatic impairment group compared with the normal hepatic function group. The maximum concentration (Cmax) and AUC values were 0.704- and 0.609-fold lower, respectively, in the ESRD group compared with the values in the other renal impairment groups; no clear differences in AUC and time to Cmax were observed in the normal function and mild, moderate, and severe renal impairment groups. There was no relationship between apparent total body clearance and estimated glomerular filtration rate. The incidence of AEs was similar among all groups. CONCLUSION:DS-8500a exposure in the mild hepatic impairment and mild to severe renal impairment groups was similar to that in the corresponding normal hepatic and renal function groups, but dose adjustments may be required in those with moderate hepatic impairment and ESRD. TRIAL REGISTRATION:Japic CTI-No. 163135. FUNDING:Daiichi Sankyo Co. Ltd., Tokyo, Japan.
journal_name
Adv Therjournal_title
Advances in therapyauthors
Kato M,Ishizuka H,Taguchi T,Shiosakai K,Kamiyama E,Sata M,Yoshida Tdoi
10.1007/s12325-018-0739-4subject
Has Abstractpub_date
2018-08-01 00:00:00pages
1239-1250issue
8eissn
0741-238Xissn
1865-8652pii
10.1007/s12325-018-0739-4journal_volume
35pub_type
杂志文章abstract::The tolerability of brimonidine tartrate 0.15%--referred to as bromonidine-Purite 0.15% in this study--was compared with brimonidine tartrate 0.2% in irritated eyes of healthy volunteers as well as patients with glaucoma or ocular hypertension (N=20) in a 2-week, single-center, randomized, double-masked, crossover stu...
journal_title:Advances in therapy
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1007/BF02849799
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abstract:INTRODUCTION:The 1100delC CHEK2 allele has been associated with a 1.4-to 4.7-fold increased risk of breast cancer in women carrying this mutation. Our study investigated the frequency of this allele in a Chinese population. METHODS:Using touchdown polymerase chain reaction, we sequenced the CHEK2.1100delC mutation in ...
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journal_title:Advances in therapy
pub_type: 杂志文章,多中心研究
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abstract:INTRODUCTION:Phase IV post-marketing surveillance studies are needed to evaluate the real-world safety and effectiveness of drug products. This study aimed to evaluate the safety and effectiveness of biosimilar etanercept (Altebrel, AryoGen Co., Iran) in patients with rheumatoid arthritis (RA), ankylosing spondylitis (...
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journal_title:Advances in therapy
pub_type: 杂志文章,评审
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journal_title:Advances in therapy
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1007/BF02868027
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pub_type: 杂志文章,评审
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journal_title:Advances in therapy
pub_type: 杂志文章,多中心研究,随机对照试验
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abstract:INTRODUCTION:Increasing dialysate magnesium (D-Mg2+) appears to be an intriguing strategy to obtain cardiovascular benefits in subjects with end-stage kidney disease (ESKD) on hemodialysis. To date, however, hemodialysis guidelines do not suggest to increase D-Mg2+ routinely set at 0.50 mmol/L. METHODS:A randomized 4-...
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pub_type: 杂志文章
doi:10.1007/s12325-020-01505-9
更新日期:2020-12-01 00:00:00
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journal_title:Advances in therapy
pub_type: 临床试验,杂志文章,随机对照试验
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更新日期:2002-01-01 00:00:00
abstract:INTRODUCTION:The anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI) alectinib was approved in Japan in 2014 for the treatment of ALK fusion gene-positive advanced non-small cell lung cancer (NSCLC). With the approvals of crizotinib in 2012 and ceritinib in 2017, Japan became the first country with multipl...
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doi:10.1007/s12325-020-01392-0
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pub_type: 已发布勘误
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journal_title:Advances in therapy
pub_type: 杂志文章,meta分析
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pub_type: 杂志文章,评审
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