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临床试验/EUCTR2010-020826-17-CZ
EUCTR2010-020826-17-CZ进行中（未招募）不适用

An open-label, non-randomized pharmacokinetic and safety study of repeat doses of fluticasone furoate and GW642444M combination in healthy subjects and in subjects with severe renal impairment

GlaxoSmithKline Research & Development Ltd0 个研究点目标入组 18 人开始时间: 2010年8月5日最近更新:
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适应症

试验速览

阶段
不适用
状态
进行中（未招募）
入组人数
18
研究概览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 clinical trial of medicinal product

入排标准

性别
All

入选标准

  • •1. Male or female between 18 and 70 years of age inclusive, at the time of signing the informed consent.
  • •2. 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; 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 (<140 pmol/L) (healthy subjects only) 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 in Section 8.1 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 and agrees to use one of the contraception methods
  • •listed in Section 8.1 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 completion of the follow-up visit.
  • •3. BMI within the range 19.0 – 33.0 kg/m2 (inclusive).
  • •4. Capable of giving written informed consent, which includes compliance with the
  • •requirements and restrictions listed in the consent form.
  • •5. Single QTcF < 450 msec; or QTcF < 480 msec in subjects with Bundle Branch
  • •6. Able to satisfactorily use the dry powder inhaler.
  • •Healthy Subjects
  • •7. 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 or outcome.
  • •8. AST, ALT, alkaline phosphatase and bilirubin = 1.5xULN (isolated bilirubin
  • •>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
  • •9. Creatinine clearance > 80mL/min calculated by the Cockcroft-Gault equation using
  • •serum creatinine.
  • •Renally Impaired Subjects
  • •10. AST and ALT < 2xULN; alkaline phosphatase and bilirubin = 1.5xULN (isolated
  • •bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin
  • •11. Creatinine clearance < 30mL/min calculated by the Cockcroft-Gault equation using
  • •serum creatinine.
  • •12. Subjects with renal insufficiency must have stable renal function defined as = 25%
  • •difference in creatinine clearance assessed on two occasions. Renal function will be
  • •based on estimated creatinine clearance (CLcr) calculated by the Cockcroft-Gault
  • •equation using serum creatinine obtained on two occasions separated by at least 4
  • •weeks within the last 3 months (historic data is permitted for the first measurement).
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • 另有 1 项未显示

排除标准

  • •1. Suffered a lower respiratory tract infection in the 4 weeks before the screening visit.
  • •2. Taken oral corticosteroids less than 8 weeks before the screening visit.
  • •3. Taken inhaled, intranasal or topical steroids less than 4 weeks before the screening visit.
  • •4. Any subject with either documented cirrhosis or a history consistent with a diagnosis of cirrhosis.
  • •5. A positive pre-study drug/alcohol screen.
  • •6. A positive test for HIV antibody.
  • •7. The subject has participated in a clinical trial and has received an investigational
  • •product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the
  • •investigational product (whichever is longer).
  • •8. Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
  • •9. Use of nephrotoxic medications 4 weeks before dosing.
  • •10. Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
  • •11. Pregnant females as determined by positive serum or urine hCG test at screening or prior to dosing.
  • •12. Lactating females.
  • •13. The subject has been treated for or diagnosed with depression within six months of screening or has a history of significant psychiatric illness.
  • •14. Unwillingness or inability to follow the procedures outlined in the protocol.
  • •15. Subject is mentally or legally incapacitated.
  • •16. History of sensitivity to heparin or heparin-induced thrombocytopenia.
  • •17. Subjects with smoking history of >10 cigarettes per day or regular use of tobacco- or nicotine-containing products, within 6 months prior to screening.
  • •18. History of severe milk protein allergy.
  • •19. Any adverse reaction including immediate or delayed hypersensitivity to any beta2- agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy. Known or suspected sensitivity to the constituents of the Novel DPI (i.e., lactose or magnesium stearate). History of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
  • •20. 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 medication.
  • •Healthy Subjects
  • •21. If, in the opinion of the examining physician, an unstable cardiovascular, renal,
  • •hepatic, pulmonary, endocrine, metabolic, neurological, haematological or
  • •gastrointestinal condition is present or any other medical condition which the
  • •investigator considers sufficiently serious to interfere with the conduct, completion,
  • •or results of this trial or constitutes an unacceptable risk to the subject.
  • •22. Subjects with any predisposing condition that might interfere with the absorption, distribution, metabolism or excretion of drugs or any previous gastrointestinal (GI) surgery please view page 25 of the protocol for further information.
  • •23. Urinary tract or bladder infection within 4 weeks of the first scheduled administration of study drug.
  • •24. A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody
  • •result within 3 months of screening.
  • •25. Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
  • •26. History of regular alcohol consumption within 6 months of the study defined as:

研究者

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