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LEO 27847 - Single Dose Bioavailability Study of Oral Solution Versus Tablet in Healthy Subjects

2013年12月10日 更新者:LEO Pharma

LEO 27847 - A Single Dose Bioavailability Study of Oral Solid Dosage Form Versus Oral Solution Including Fed Versus Fasted State in Healthy Male Subjects

The purpose of this phase 1 study is to determine the relative bioavailability following single oral dose administration of LEO 27847 solution compared to LEO 27847 tablets in healthy male subjects as well as to determine the effect of food on the single oral dose pharmacokinetics of LEO 27847 tablets in healthy male subjects.

研究概览

地位

完全的

条件

研究类型

介入性

注册 (实际的)

20

阶段

  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Leeds、英国
        • Covance Clinical Research Unit Ltd.

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 45年 (成人)

接受健康志愿者

是的

有资格学习的性别

男性

描述

Inclusion Criteria:

  • Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions.
  • Subjects will be Caucasian males between 18 and 45 years of age, with body mass index (BMI) between 18 and 32 kg/m2 inclusive.
  • Subjects will have a minimum weight of 50 kg
  • Subjects must be in good health, as determined by a medical history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations (congenital non haemolytic hyperbilirubinaemia is acceptable)

Exclusion Criteria:

  • male subjects who are not willing to use appropriate contraception (such as condom) and for female partners; occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository) from the time of the first dose until 3 months after the final dosing occasion.
  • Subjects who have received any prescribed systemic or topical medication within 7 days of the first dose administration unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise safety
  • Subjects who have used any non-prescribed systemic or topical medication (including herbal remedies) within 7 days of the first dose administration unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise safety
  • Subjects who have received any medications, including St John's Wort, known to chronically alter drug absorption or elimination processes within 30 days of the first dose administration unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise safety
  • Subjects who are still participating in a clinical study (e.g. attending follow-up visits) or who have participated in a clinical study involving administration of an investigational drug (new chemical entity), or a marketed drug within the past 3 months prior to the first dosing occasion.
  • Subjects who have donated any blood, plasma or platelets in the month prior to screening or who have made donations on more than two occasions within the 12 months preceding the first dose administration
  • Subjects with a significant history of drug allergy as determined by the Investigator
  • Subjects who have any clinically significant allergic disease (excluding non-active hay fever) as determined by the Investigator
  • Subjects who have a supine blood pressure and supine pulse rate at screening higher than 140/90 mmHg and 100 beats per minute (bpm), respectively, or lower than 90/50 mmHg and 45 bpm, respectively, confirmed by repeat
  • Subjects who consume more than 28 units of alcohol per week or who have a significant history of alcoholism or drug/chemical abuse as determined by the Investigator
  • Subjects who smoke, or who have smoked within 3 months prior to first dose administration
  • Subjects with, or with a history of, any clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, haematological, dermatological or other major disorders as determined by the Investigator
  • Subjects who have had a clinically significant illness within 4 weeks of the start of dose administration as determined by the Investigator
  • Subjects who are known to have hepatitis, or who are carriers of the hepatitis B surface antigen (HBsAg) or hepatitis C antibody, or who have a positive result to the test for HIV
  • Subjects who, in the opinion of their General Practitioner (GP) or the Investigator, should not participate in the study, including subjects suspected for whatever reason of not being able to comply with the requirements of the protocol

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 分配:随机化
  • 介入模型:交叉作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:LEO 27847 oral solution 0.1 mg
实验性的:LEO 27847 tablet 0.10 mg
实验性的:LEO 27847 tablet 0.01 mg

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
PK parameters
大体时间:7 weeks
AUC and Cmax in each group
7 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2010年6月1日

初级完成 (实际的)

2010年8月1日

研究完成 (实际的)

2010年9月1日

研究注册日期

首次提交

2010年6月1日

首先提交符合 QC 标准的

2010年6月11日

首次发布 (估计)

2010年6月14日

研究记录更新

最后更新发布 (估计)

2013年12月11日

上次提交的符合 QC 标准的更新

2013年12月10日

最后验证

2010年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • LEO 27847-K01

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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