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The purpose of this study is to study pharmacokinetics in adolescents.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | AZD1981 100 mg twice daily for 6 ½ days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD1981 100 mg twice daily for 61/2 days | Drug | 100 mg tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary steady-state outcome variables to assess systemic exposure and oral clearance will be AUCÏ„, Css,max, Css,trough, and CL/F of AZD1981 | 0 hours after last dose | |
| The primary steady-state outcome variables to assess systemic exposure and oral clearance will be AUCÏ„, Css,max, Css,trough, and CL/F of AZD1981 | 0.5, hours after last dose | |
| The primary steady-state outcome variables to assess systemic exposure and oral clearance will be AUCÏ„, Css,max, Css,trough, and CL/F of AZD1981 | 1 hour after last dose | |
| The primary steady-state outcome variables to assess systemic exposure and oral clearance will be AUCÏ„, Css,max, Css,trough, and CL/F of AZD1981 | 3 hours after last dose | |
| The primary steady-state outcome variables to assess systemic exposure and oral clearance will be AUCÏ„, Css,max, Css,trough, and CL/F of AZD1981 | 4 hours after last dose | |
| The primary steady-state outcome variables to assess systemic exposure and oral clearance will be AUCÏ„, Css,max, Css,trough, and CL/F of AZD1981 | 6 hours after last dose | |
| The primary steady-state outcome variables to assess systemic exposure and oral clearance will be AUCÏ„, Css,max, Css,trough, and CL/F of AZD1981 | 8 hours after last dose | |
| The primary steady-state outcome variables to assess systemic exposure and oral clearance will be AUCÏ„, Css,max, Css,trough, and CL/F of AZD1981 | 12 hours after last dose |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christer Hultquist | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Uppsala | Uppsala County | Sweden |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C569518 | AZD1981 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |