Pharmacokinetics in Adolescents

Asthma Clinical Trial

— PEAK  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01196689
• Other study ID #: D9830C00021
• Status: Completed
• Phase: Phase 1
• First received: August 31, 2010
• Last updated: March 4, 2011
• Start date: October 2010
• Est. completion date: February 2011

Study information

• Verified date: March 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to study pharmacokinetics in adolescents.

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 information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 12 Years to 17 Years

Eligibility

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

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• AZD1981 100 mg twice daily for 61/2 days
100 mg tablets

Locations

Country	Name	City	State
Sweden	Research Site	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		0 hours after last dose	No
Primary	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		0.5, hours after last dose	No
Primary	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		1 hour after last dose	No
Primary	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		3 hours after last dose	No
Primary	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		4 hours after last dose	No
Primary	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		6 hours after last dose	No
Primary	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		8 hours after last dose	No
Primary	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		12 hours after last dose	No
Secondary	Tolerability and safety assessed by adverse events		During 7 days	No
Secondary	Efficacy assessed by Forced Expiratory Volume (FEV) in one second and Asthma Control Questionnaire		Day 1 and 7	No