EUCTR2010-021520-10-SE进行中（未招募）不适用
An open, single centre, phase I study in male adolescents with asthma, aged12 to 17 years, to assess pharmacokinetics of orally administered AZD1981 tablets 100mg twice daily for 6½ days
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 21
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
- Male
入选标准
- •1. Provision of signed and dated informed consent prior to any study specific procedures from both the patient and the patient’s parents/legal guardians is required.
- •2. Male adolescents, aged 12-17 years (inclusive).
- •3. A minimum of 6 months documented history of asthma.
- •4. Pre-bronchodilator FEV1 =75% of the predicted normal (PN) value.
- •5. If applicable, patients must be willing to use barrier methods of contraception, unless their partners are using accepted contraceptive methods.
- •6. Be non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for >6 months prior to study start.
- •For inclusion in the genetic component of the study, patients must fulfil the following
- •additional criterion:
- •7. Provision of signed, written and dated informed consent by patient’s parents/legal
- •guardians for genetic research. If a patients declines to participate in the genetic
- •component of the study, there will be no penalty or loss of benefit to the patient.
- •The patient will not be excluded from other aspects of the study described in the
- •CSP, as long as they consent.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Any clinically significant disease or disorder (e.g. cardiovascular, pulmonary other than asthma, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment,) which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or influence the result of the study, or the patient’s ability to participate in the study.
- •2. Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs, or ECG at baseline, which, in the opinion of the investigator, may put the patient at risk because of his participation in the study.
- •3. QTcF > 450 ms or QT > 500 ms or other ECG abnormality making interpretation more difficult, as judged by the investigator.
- •4. Use of any medication, herbal preparations, vitamins or nutritional supplements within 4 weeks prior to Visit 3, except for inhaled asthma medication and occasional intake of paracetamol as well as over-the-counter (OTC) adrenergic nasal spray for relief of nasal congestion, if needed.
- •5. A definite or suspected personal history of intolerance or hypersensivity to drugs and/or their excipients, judged to be clinically relevant by the investigator.
- •6. History of or current alcohol or drug abuse, as judged by the investigator.
- •7. A suspected/manifested infection according to International Air Transport Association (IATA) Categories A and B infectious substances.
- •8. Positive results on screening tests for hepatitis B and/or C and/or HIV.
- •9. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff and staff at the investigational site).
- •10. Participation in another investigational drug study within 3 months before Visit 3, or participation in a method development study (no drug) 1 month prior to Visit 3 .
- •11. Planned in-patient surgery , dental procedure or hospitalisation during the study.
- •12. Patients who, in the opinion of the investigator, should not participate in the study.
- •13.Previous enrolment in the present study.
- •Any of the following is regarded as criterion for exclusion from the pharmacogenetic part of the study:
- •14. Previous allogeneic bone marrow transplant.
- •15. Non-Leukocyte depleted whole blood transfusion within 120 days of genetic sample collection.
研究者
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