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Pharmacokinetics in Adolescents (PEAK)

Primary Purpose

Asthma

Status
Completed
Phase
Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
AZD1981 100 mg twice daily for 61/2 days
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Asthma focused on measuring Pharmacokinetics AZD1981, Asthma

Eligibility Criteria

12 Years - 17 Years (Child)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Research Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

AZD1981 100 mg twice daily for 6 ½ days

Outcomes

Primary Outcome Measures

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
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
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
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
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
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
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
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

Secondary Outcome Measures

Tolerability and safety assessed by adverse events
Efficacy assessed by Forced Expiratory Volume (FEV) in one second and Asthma Control Questionnaire

Full Information

First Posted
August 31, 2010
Last Updated
March 4, 2011
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT01196689
Brief Title
Pharmacokinetics in Adolescents
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Pharmacokinetics AZD1981, Asthma

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
AZD1981 100 mg twice daily for 6 ½ days
Intervention Type
Drug
Intervention Name(s)
AZD1981 100 mg twice daily for 61/2 days
Intervention Description
100 mg tablets
Primary Outcome Measure Information:
Title
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
Time Frame
0 hours after last dose
Title
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
Time Frame
0.5, hours after last dose
Title
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
Time Frame
1 hour after last dose
Title
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
Time Frame
3 hours after last dose
Title
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
Time Frame
4 hours after last dose
Title
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
Time Frame
6 hours after last dose
Title
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
Time Frame
8 hours after last dose
Title
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
Time Frame
12 hours after last dose
Secondary Outcome Measure Information:
Title
Tolerability and safety assessed by adverse events
Time Frame
During 7 days
Title
Efficacy assessed by Forced Expiratory Volume (FEV) in one second and Asthma Control Questionnaire
Time Frame
Day 1 and 7

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christer Hultquist
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Uppsala
Country
Sweden

12. IPD Sharing Statement

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Pharmacokinetics in Adolescents

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