Pharmacokinetics in Adolescents
Phase 1
Completed
- Conditions
- Asthma
- Interventions
- Drug: AZD1981 100 mg twice daily for 61/2 days
- Registration Number
- NCT01196689
- Lead Sponsor
- AstraZeneca
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 21
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 AZD1981 100 mg twice daily for 61/2 days AZD1981 100 mg twice daily for 6 ½ days
- Primary Outcome Measures
Name Time Method 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 12 hours after last dose
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Research Site
🇸🇪Uppsala, Sweden