Asthma MedDRA version: 12.1 Level: LLT Classification code 10003553 Term: Asthma
Conditions
Interventions
Product Name: AZD1981
Product Code: AZD1981
Pharmaceutical Form: Film-coated tablet
CAS Number: 802904-66-1
Current Sponsor code: AZD1981
Concentration unit: mg milligram(s)
Concentration type: equal
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to investigate the PK of orally administered AZD1981 in male adolescents with asthma. ;Secondary Objective: The secondary objectives of the study are: i) To evaluate the tolerability and safety of AZD1981 ii) To evaluate efficacy of AZD1981 ;Primary end point(s): The primary steady-state outcome variables to assess systemic exposure and oral clearance will be AUCt, Css,max, Css,trough, and CL/F of AZD1981. | — |
Countries
Sweden
Outcome results
None listed