A Single Center, Randomized, Open-Label, Sequential, Single Dose, 4-Period Crossover Study to Evaluate the Bioavailability and Food Effect of a Gelatin Formulation and Two Prototype Formulations of Afuresertib, an AKT Inhibitor, in Normal Healthy Volunteers.

GlaxoSmithKline0 个研究点目标入组 36 人开始时间: 2013年4月15日最近更新: 2020年1月13日

适应症

试验速览

阶段: 1 期
状态: 尚未招募
发起方: GlaxoSmithKline
入组人数: 36

研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Randomised controlled trial
主要目的: Treatment
盲法: Open (masking not used)

入排标准

年龄范围: 18 Years 至 40 Years（—）
性别: All

入选标准

•1. Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
•2. Male or female between 18 and 40 years of age inclusive, at the time of signing the informed consent.
•3. Body weight greater than or equal to 50 kg and BMI less than or equal to 32 kg/m2.
•4. A female subject is eligible to participate if she is of:
•*Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy [for this definition, documented” refers to the outcome of the Investigator's/designee’s review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject’s medical records]; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol < 40 pg/ml (<147 pmol/L) is confirmatory]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods permitted as per protocol if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.
•* Child-bearing potential with negative pregnancy test as determined by serum hCG test at Screening and prior to dosing, AND;
•a. Agrees to use one of the contraception methods listed in the protocol for an appropriate period of time (as determined by the product label or Investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until 14 days (2 weeks) post last dose.
•b. OR has only same-sex partners, when this is her preferred and usual lifestyle.
•5. Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods as listed in the protocol. This criterion must be followed from the time of the first dose of study drug until 14 days (2 weeks) post last dose.
•6. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
•7. ALT, alkaline phosphatase and bilirubin equal to or less than 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
•8. Based on single or averaged QTc values of triplicate ECGs obtained over a brief recording period:
•*QTc < 450 msec; or
•*QTc < 480 msec in subjects with Bundle Branch Block.

排除标准

•1. Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
•2. History of GERD, dyspepsia, GI bleeding, GI surgery that could affect motility.
•3. History of atrial arrhythmias
•4. History of regular alcohol consumption within 6 months of the study defined as:
•'an average weekly intake of >21 units for males or >14 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (~240 ml) of beer, 1 glass (125 ml) of wine or 1 (25 ml) measure of spirits'.
•5. History of sensitivity to heparin or heparin-induced thrombocytopenia.
•6. History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the Investigator or GSK Medical Monitor, contraindicates their participation.
•7. Use of prescription or non-prescription medications, vitamins, and dietary or herbal supplements (including St John’s Wort) within 7 days (or 14 days if the drug/supplement is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study drug until completion of the Follow-up Period, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study.
•8. Unable to abstain from smoking tobacco or the use of nicotine-containing products while admitted to the clinic.
•9. Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of Study Drug on Day 1 of Dosing Period 1, until completion of the Follow-up Period.

研究者

发起方

GlaxoSmithKline

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