Clinical trial NCT01196689: Pharmacokinetics in Adolescents
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Keywords: Pharmacokinetics AZD1981
Asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-09-08
Enrollment: 21
Sex: MALE
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 0 hours after last dose
measure: 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
timeFrame: 0.5, hours after last dose
measure: 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
timeFrame: 1 hour after last dose
measure: 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
timeFrame: 3 hours after last dose
measure: 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
timeFrame: 4 hours after last dose
measure: 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
timeFrame: 6 hours after last dose
measure: 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
timeFrame: 8 hours after last dose
measure: 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
timeFrame: 12 hours after last dose
Secondary outcomes:
measure: Tolerability and safety assessed by adverse events
timeFrame: During 7 days
measure: Efficacy assessed by Forced Expiratory Volume (FEV) in one second and Asthma Control Questionnaire
timeFrame: Day 1 and 7
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Christer Hultquist
role: STUDY_DIRECTOR
References: