A Randomized, Open-Label, Crossover Phase 1 Study to Evaluate the Effects of Food on the Pharmacokinetics of a Single Oral Dose of a 15-mg Tylerdipine Tablet in Healthy Chinese Male Volunteers [0.03%]
一项在健康中国男性受试者中评价食物影响单次口服15 mg泰拉匹地平片后药代动力学的 I 期、开放标签、交叉试验
Lu Wang,Lijun Xie,Sufeng Zhou et al.
Lu Wang et al.
Tylerdipine hydrochloride is a novel L-type and T-type dual calcium channel antagonist that has the potential effects of expanding blood vessels and lowering blood pressure. It is expected to reduce the side effect of ankle edema observed w...
Evaluation of the Safety, Tolerability, and Pharmacokinetics of GSK2269557 (Nemiralisib) Administered Via Dry Powder Inhaler to Healthy Japanese Subjects [0.03%]
GSK2269557（Nemiralisib）干粉吸入剂在日本健康受试者中的安全性和耐受性以及药代动力学研究评价
Hiroko Ino,Robert Wilson,Takumi Terao et al.
Hiroko Ino et al.
The aim of the study was to assess the safety, tolerability, and pharmacokinetics of single and repeat doses of nemiralisib administered via a dry powder inhaler to healthy Japanese subjects. This was a single-center, double-blind, randomiz...
Randomized Controlled Trial
Clinical pharmacology in drug development. 2019 Jan;8(1):78-86. DOI:10.1002/cpdd.614 2019
First-in-Human Studies for a Selective RET Tyrosine Kinase Inhibitor, GSK3179106, to Investigate the Safety, Tolerability, and Pharmacokinetics in Healthy Volunteers [0.03%]
选择性RET酪氨酸激酶抑制剂GSK3179106首次人体试验：在健康志愿者中考察其安全性、耐受性和药代动力学特征的研究
Melisa Cooper,Robin O&#x;Connor-Semmes,Beth Ann Reedy et al.
Melisa Cooper et al.
Rearranged during transfection (RET), a neuronal growth factor receptor tyrosine kinase, regulates the development of the sympathetic, parasympathetic, motor, and sensory neurons in the enteric nervous system. GSK3179106 is a RET kinase inh...
Randomized Controlled Trial
Clinical pharmacology in drug development. 2019 Feb;8(2):234-245. DOI:10.1002/cpdd.600 2019
Distribution, Metabolism, and Excretion of Gedatolisib in Healthy Male Volunteers After a Single Intravenous Infusion [0.03%]
单次静脉输注gedatolisib后健康男性受试者的分布、代谢和排泄
Brett E Houk,Christine W Alvey,Ravi Visswanathan et al.
Brett E Houk et al.
In this open-label study (NCT02142920), we investigated the distribution, pharmacokinetics, and metabolism of the pan-class-I isoform phosphatidylinositol 3-kinase/mammalian target of rapamycin inhibitor gedatolisib (PF-05212384), following...
A Phase 1 Assessment of the QT Interval in Healthy Adults Following Exposure to Rolapitant, a Cancer Supportive Care Antiemetic [0.03%]
塞来昔布在健康成人中对QT间期影响的Ⅰ期评估研究
Xiaodong Wang,Zhi-Yi Zhang,Jing Wang et al.
Xiaodong Wang et al.
This 2-part study evaluated the QT/QTc prolongation potential and safety and pharmacokinetics of the antiemetic rolapitant, a neurokinin-1 receptor antagonist. Part 1 was a randomized, placebo-controlled single-dose-escalation study assessi...
Pharmacokinetics and Safety of CSL112 (Apolipoprotein A-I [Human]) in Adults With Moderate Renal Impairment and Normal Renal Function [0.03%]
CSL112（人载脂蛋白A-I）在中度肾功能不全和正常肾功能成人受试者中的药代动力学和安全性研究
Michael A Tortorici,Danielle Duffy,Rebecca Evans et al.
Michael A Tortorici et al.
CSL112 (Apolipoprotein A-I [human]) is an intravenous preparation of apolipoprotein A-I (apoA-I), formulated with phosphatidylcholine (PC) and stabilized with sucrose, in development to prevent early recurrent cardiovascular events followin...
Effect of a High-Fat Meal on the Pharmacokinetics of the HIV Integrase Inhibitor Cabotegravir [0.03%]
高脂肪饮食对人类免疫缺陷病毒整合酶抑制剂卡博特格拉韦药代动力学的影响
Parul Patel,Susan L Ford,Yu Lou et al.
Parul Patel et al.
Cabotegravir is an integrase inhibitor in clinical development for the treatment and prevention of HIV infection using oral tablets for short-term, lead-in use before subsequent administration of a long-acting injectable formulation. This p...
Pharmacokinetics, Excretion, and Mass Balance of [14 C]-Batefenterol Following a Single Microtracer Intravenous Dose (Concomitant to an Inhaled Dose) or Oral Dose of Batefenterol in Healthy Men [0.03%]
单次微示踪剂静脉给药（伴随吸入给药）或口服给药后 [14 C]-Batefenterol 的药代动力学、排泄和物料平衡（健康男性）
Claire Ambery,Graeme Young,Teresa Fuller et al.
Claire Ambery et al.
Inhaled batefenterol is an investigational bifunctional molecule for the treatment of chronic obstructive pulmonary disease. The excretion balance and pharmacokinetics of batefenterol using [14 C]-radiolabeled drug administered orally and a...
Relative and Absolute Bioavailability Study of Emicizumab to Bridge Drug Products and Subcutaneous Injection Sites in Healthy Volunteers [0.03%]
在健康志愿者中进行的emicizumab交叉生物等效性和绝对生物利用度研究：不同药物产品和皮下注射位点之间的桥接研究
Naoki Kotani,Koichiro Yoneyama,Nobuhiko Kawakami et al.
Naoki Kotani et al.
Emicizumab (ACE910) is a bispecific antibody that is a novel, subcutaneously injectable treatment for patients with hemophilia A. This study assessed the relative bioavailability of emicizumab between old and new drug products (DPs) and amo...
Randomized Controlled Trial
Clinical pharmacology in drug development. 2019 Aug;8(6):702-712. DOI:10.1002/cpdd.617 2019
Characterizing the Sources of Pharmacokinetic Variability for TAK-117 (Serabelisib), an Investigational Phosphoinositide 3-Kinase Alpha Inhibitor: A Clinical Biopharmaceutics Study to Inform Development Strategy [0.03%]
一项临床生物药剂学研究：描述在研磷脂酰肌醇-3-激酶α抑制剂TAK-117（塞博利西布）的药代动力学变异来源以指导研发策略
Chirag G Patel,Lakshmi Rangachari,Mark Patti et al.
Chirag G Patel et al.
TAK-117 (also known as MLN1117 or serabelisib) is an orally available inhibitor of phosphoinositide 3-kinase alpha being developed for treatment of solid tumors. This clinical study in healthy subjects assessed the relative bioavailability ...
Randomized Controlled Trial
Clinical pharmacology in drug development. 2019 Jul;8(5):637-646. DOI:10.1002/cpdd.613 2019