Asthma
Conditions
Keywords
Pharmacokinetics AZD1981, Asthma
Brief summary
The purpose of this study is to study pharmacokinetics in adolescents.
Detailed description
An open, single centre, phase I study in male adolescents with asthma, aged 12 to 17 years, to assess pharmacokinetics of orally administered AZD1981 tablets 100 mg twice daily for 61/2 days.
Interventions
DRUGAZD1981 100 mg twice daily for 61/2 days
100 mg tablets
Sponsors
AstraZeneca
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Provision of informed consent prior to any study specific procedures * A minimum of 6 months documented history of asthma * Be a non-smoker or ex-smoker who has stopped smoking for \>6 months prior to Visit 1 (pre-entry)
Exclusion criteria
* Any clinically significant disease or disorder 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 * Any clinically relevant abnormal findings in phys.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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary steady-state outcome variables to assess systemic exposure and oral clearance will be AUCτ, Css,max, Css,trough, and CL/F of AZD1981 | 0 hours after last dose |
Secondary
| Measure | Time frame |
|---|---|
| Tolerability and safety assessed by adverse events | During 7 days |
| Efficacy assessed by Forced Expiratory Volume (FEV) in one second and Asthma Control Questionnaire | Day 1 and 7 |
Countries
Sweden
Outcome results
None listed