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临床试验/EUCTR2012-002567-99-GB
EUCTR2012-002567-99-GB进行中（未招募）不适用

An integrated Phase I/IIa study to evaluate the safety, tolerability and pharmacokinetics of single ascending doses of inhaled GRC 17536 in healthy adult volunteers and multiple ascending doses in patients with mild asthma; and randomised, double-blind, placebo controlled, cross-over study to evaluate the effects of multiple doses of inhaled GRC 17536 on late phase asthmatic response to allergen challenge in patients with mild asthma. - To study safety, tolerability, PK and efficacy of inhaled GRC 17536

Glenmark Pharmaceuticals SA0 个研究点开始时间: 2012年7月23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）
发起方
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

  • •Part 1 (SAD): Healthy subjects
  • •1. Subjects who are able and willing to give written informed consent;
  • •2. Male subjects aged 18 to 50 years inclusive;
  • •3. Weight =50 kg;
  • •4. Body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive;
  • •5. Healthy as determined by pre-study medical history, physical examination, and 12-lead ECG;
  • •6. Non-smokers or ex-smokers for at least 12 months with less than a 10-pack per year history;
  • •7. Clinical laboratory tests within the reference ranges or clinically acceptable to the Investigator;
  • •8. Negative screens for drugs of abuse and alcohol (urine) at screening and admission. Subjects must test negative for the following: amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, ethanol, opiates and cotinine;
  • •9. Medical history must be verified by either a personal physician or medical practitioner as appropriate
  • •10. Male subjects should agree not to not donate sperm for 3 months post last dose; and
  • •11. Female partners (of child bearing potential) of male subjects should use 2 methods of highly effective contraception for 3 months post last dose.
  • •Parts 2 (MAD) and 3 (Allergen challenge):
  • •1. Subjects who are able and willing to give written informed consent
  • •2. Male and non-childbearing female subjects aged 18 to 65 years inclusive;
  • •3. Weight =50 kg;
  • •4. Body mass index (BMI) between 18.0 and 32.0 kg/m2 inclusive
  • •5. Female subjects should be of non-child bearing potential, either surgically sterile or post menopausal for 2 years prior to screening, as confirmed by follicle stimulating hormone (FSH) and luteinizing hormone (LH);
  • •6. Male subjects should agree to not donate sperm from first dose until 3 months post last dose
  • •7. Two methods of highly effective contraception should be used if the female partner of a male subject is of child bearing potential (Section 9.4.1)
  • •8. Steroid-naïve subjects with mild asthma for at least 6 months that satisfy the Global Initiative for Asthma (GINA) (6) definition of asthma, but otherwise healthy;
  • •9. Non-smokers or ex-smokers for at least 12 months with less than a 10 pack year history;
  • •10. Not taking any concomitant anti-asthma (except short-acting inhaled ß2-agonists or anti-allergy medication (except antihistamines) for at least 6 weeks prior to screening visit and willing to continue throughout the study period;
  • •11. Pre-bronchodilator FEV1 of >70% of the predicted normal value for age, height and sex at screening and prior to first dose administration;
  • •12. Positive methacholine with a provocative concentration of methacholine resulting in a 20% fall in FEV1 (PC20 methacholine) of equal to or less than 8 mg/mL at screening (Part 3 only);
  • •13. Documented allergy to at least one common allergen (house dust mite, pollen allergens or cat dander) as confirmed by a skin prick test wheal =3 mm in diameter). Historical data (up to 1 year) may be used (Part 3 only);
  • •14. Early asthmatic response (EAR) (FEV1 fall of = 20%, 0 to 60 minutes after allergen challenge) and LAR (FEV1 fall of =15% 3 to 8 hours after challenge) (Part 3 only); and.
  • •15. Able to provide an acceptable a sputum sample which is suitable for analysis (Part 3 only).
  • •To be randomised on Day 1 in Part 3, subjects must have:
  • •Compliance with withholding of disallowed concomitant medication.
  • •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 84
  • •F.1.3 Elderly (>=65 years) no

排除标准

  • •Part 1 (SAD): Healthy subjects
  • •1. Subjects with evidence or history of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease;
  • •2. Subjects with a supine systolic blood pressure (SBP) =160 mmHg and/or a supine diastolic blood pressure (DBP) =100 mmHg;
  • •3. History of alcohol abuse or drug addiction as seen on positive screen on drugs of abuse or positive alcohol test;
  • •4. Positive screen on hepatitis B surface antigen (HBsAg), antibodies to the hepatitis C virus (HCV) or antibodies to the human immunodeficiency virus (HIV) 1/2;
  • •5. 12-lead ECG demonstrating QTcF >450 ms at screening;
  • •6. Abnormal liver function tests;
  • •7. Current diagnosis of active epilepsy or any active seizure disorder;
  • •8. Subjects who have a significant infection or known inflammatory process on screening or admission;
  • •9. Subjects who have acute gastrointestinal symptoms at the time of screening or admission;
  • •10. Subjects who have an acute infection such as influenza at the time of screening or admission;
  • •11. Subjects who have received any investigational drug (including GRC 17536) in any clinical trial within 3 months, or who are on extended follow-up;
  • •12. Subjects who do not agree to use medically acceptable methods of contraception;
  • •13. Strong or moderate inhibitors or inducers of CYP3A4;
  • •14. Herbal medication/supplements, St John’s Wort and grapefruit juice for 14 days prior to screening;
  • •Parts 2 (MAD) and 3 (Allergen challenge):
  • •1. Subjects with evidence or history of clinically significant haematological, renal, endocrine, pulmonary (excluding mild asthma), gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
  • •2. Worsening of asthma in the 4 weeks preceding the screening visit (requiring daily use of nebulised ß2-agonists or any use of long acting ß agonists (LABA), or requiring in-patient hospitalisation for asthma control, or requiring emergency room treatment, or requiring systemic corticosteroids for asthma control) or respiratory infection in the 4 weeks preceding the screening visit or during the admission period 1;
  • •3. Use of any immunotherapy within 3 months prior to screening;
  • •4. Use of nasal or inhaled corticosteroids, intraophthalmic corticosteroids, nasal, inhaled, or intraophthalmic cromolyn sodium or nedocromil, leukotriene receptor antagonists and 5-lipoxygenase inhibitors within 6 weeks prior to screening;
  • •5. Patient on LABA and long-acting anti cholinergics;
  • •6. History of life-threatening asthma,
  • •7. Symptomatic with allergic rhinitis (eg, hay fever), requiring treatment, at screening or predicted to have symptomatic allergic rhinitis (eg, hay fever) during the time of study, requiring treatment;
  • •8. History of serious adverse reaction, severe hypersensitivity or allergy to any drug or in any other circumstance (e.g. anaphylaxis);
  • •9. Clinically significant abnormalities in physical examination and/or in laboratory test results (including haematology and chemistry panels, urinalysis) as assessed by the Investigator;
  • •10. Subjects who have received any investigational drug (including GRC 17536) in any clinical trial within 3 months, or who are on extended follow-up;
  • •11. Current diagnosis of active epilepsy or any active seizure disorder requiring chronic therapy with anti-epileptic drug(s);
  • •12. Strong or moderate inhibitors or inducers of CYP3A4
  • •13. Herbal medication/supplements

研究者

发起方
Glenmark Pharmaceuticals SA

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