EUCTR2006-006083-33-NL进行中（未招募）1 期
A randomised, double-blind, placebo-controlled, dose ascending, 2-cohort, parallel group study to examine the safety, tolerability, pharmacokinetics and pharmacodynamics of twice-daily inhaled doses of GSK233705B formulated with the excipient Magnesium Stearate in COPD subjects for 7-days. - GSK233705B pk and pd study in COPD patients
GlaxoSmithKline Research and Development Ltd0 个研究点目标入组 0 人开始时间: 2007年2月14日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Men or women who are between 40 and 75 years of age
- •2. Female subjects must be of non-childbearing potential including pre-menopausal females with documented (medical report verification) hysterectomy or double oophrectomy or postmenopausal defined as 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.
- •3. Subject diagnosed with COPD, as defined by the GOLD guidelines (see Appendix 5)
- •4. Body Mass Index 18.0 - 32.0 kg/m2 (inclusive)
- •5. Subject is a smoker or an ex-smoker with a smoking history of at least 10 pack years (1 pack year = 20 cigarettes smoked per day for 1 year or equivalent).
- •6. Subject has post-bronchodilator (200µg salbutamol) FEV1 of = 40% to = 80% of predicted normal.
- •7. Subject has FEV1/FVC < 0.7 post-bronchodilator (200µg salbutamol).
- •8. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- •9. Subject is available to complete all study measurements and procedures.
- •10. Subjects have a 24hr holter recording that is within normal limits and does not demonstrate any clinically important abnormality that, in the opinion of the investigator, would make the subject unsuitable for participation in the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Subjects who have a past or present disease, which as judged by the Investigator and the Medical Monitor, may affect the outcome of this study.
- •2. The subject has a positive pre-study alcohol screen. The detection of alcohol would not be an exclusion at screening but would need to be negative pre-dose and during the study.
- •3. The subject has a positive pre-study drug screen. A minimum list of drugs that will be screened for include Amphetamines, Barbiturates, Cocaine and Opiates. The detection of drugs with a legitimate medical use would not be an exclusion to study participation.
- •4. History of alcohol/drug abuse or dependence within 12 months of the study: Abuse of alcohol defined as an average weekly intake of greater than 24 units. 1 unit is equivalent to a half-pint (220mL) of beer or 1 (25ml) measure of spirits or 1 glass (125ml) of wine.
- •5. The subject has a positive pregnancy test.
- •6. A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- •7. The subject has participated in a clinical trial and has received a drug or a new chemical entity within 60 days or 5 half-lives, or twice the duration of the biological effect of any drug(whichever is longer) prior to the first dose of current study medication.
- •8. Exposure to more than three new chemical entities (NCE) within 10 months prior to the first dosing day or one NCE within 3 months prior to the first dosing day.
- •9. The subject has donated a unit (400ml) of blood within 60 days of screening, or, intends to donate during the study.
- •10. The subject has a known allergy or hypersensitivity to ipratropium bromide, atropine and any of its derivatives or milk protein/lactose.
- •11. History of sensitivity to any of the study medications, or components thereof (including Magnesium Stearate) or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation
- •12. Subject is unable to use the DISKUS™ device correctly.
- •13. Subject has prostate hypertrophy or narrow angle glaucoma.
研究者
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