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首页> 外文期刊>The Journal of Clinical Pharmacology: Official Journal of the American College of Clinical Pharmacology >Randomized, placebo-controlled single-ascending-dose study to evaluate the safety, tolerability and pharmacokinetics of the HIV nucleoside reverse transcriptase inhibitor, BMS-986001, in healthy subjects
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Randomized, placebo-controlled single-ascending-dose study to evaluate the safety, tolerability and pharmacokinetics of the HIV nucleoside reverse transcriptase inhibitor, BMS-986001, in healthy subjects

机译：随机，安慰剂控制的单一升序研究，评价HIV核苷逆转录酶抑制剂，BMS-986001，健康受试者的安全性，耐受性和药代动力学

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摘要

The objectives of this study were to evaluate the safety, tolerability and pharmacokinetics (PK) of BMS-986001 as a single oral dose in healthy male subjects. Sixty-four healthy male subjects were randomized to receive a single dose of BMS-986001 or placebo in this single-blind, placebo-controlled, sequential ascending-dose study. There were eight treatment groups (10, 30, 100, 300, 600, and 900mg fed; and 100 and 300mg fasted) of eight subjects each (BMS-986001 n=6/placebo n=2). BMS-986001 was well tolerated, with no serious adverse events (AEs), deaths, or discontinuations due to AEs reported. AEs were experienced by 14.6% of subjects receiving BMS-986001; however, these did not appear to be dose related and were not considered to be related to study drug. BMS-986001 was rapidly absorbed and exhibited a linear dose-exposure relationship across the dose range studied. PK appeared similar whether administered with or without food. Administration of BMS-986001 as a single dose was generally safe and well tolerated. A linear dose-exposure relationship was seen across all doses studied, with no apparent food effect. Further clinical development is warranted.
机译：本研究的目的是评估BMS-986001的安全性，耐受性和药代动力学（PK）作为健康男性受试者的单一口服剂量。在这种单一盲，安慰剂控制的顺序上升剂量研究中，六十四个健康的男性受试者被随机被随机接受单剂量的BMS-986001或安慰剂。有八个治疗组（10,30,100,300,600和900mg喂养;和100和300mg禁食）八个受试者（BMS-986001 n = 6 /安慰剂N = 2）。 BMS-986001耐受性良好，由于AES报道，没有严重的不良事件（AES），死亡或中断。 AES受到收到BMS-986001的受试者的14.6％;然而，这些似乎没有与病例相关的剂量相关，并且没有被认为与研究药物有关。 BMS-986001迅速吸收，并在研究的剂量范围内表现出线性剂量接触关系。 PK似乎类似于或没有食物。施用BMS-986001作为单一剂量通常是安全且耐受性的。在研究的所有剂量上看到线性剂量暴露关系，没有明显的食物效果。进一步的临床发展是有保证的。

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