Pharmacokinetics in Adolescents (PEAK)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01196689
First received: August 31, 2010
Last updated: March 4, 2011
Last verified: March 2011
  Purpose

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


Condition Intervention Phase
Asthma
Drug: AZD1981 100 mg twice daily for 61/2 days
Phase 1

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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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 [ Time Frame: 0 hours after last dose ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tolerability and safety assessed by adverse events [ Time Frame: During 7 days ] [ Designated as safety issue: No ]
  • Efficacy assessed by Forced Expiratory Volume (FEV) in one second and Asthma Control Questionnaire [ Time Frame: Day 1 and 7 ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: October 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
AZD1981 100 mg twice daily for 6 ½ days
Drug: AZD1981 100 mg twice daily for 61/2 days
100 mg tablets

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

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01196689

Locations
Sweden
Research Site
Uppsala, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Christer Hultquist AstraZeneca
  More Information

No publications provided

Responsible Party: Medical Science Director (MSD), AstraZeneca
ClinicalTrials.gov Identifier: NCT01196689     History of Changes
Other Study ID Numbers: D9830C00021
Study First Received: August 31, 2010
Last Updated: March 4, 2011
Health Authority: Sweden: Medical Products Agency

Keywords provided by AstraZeneca:
Pharmacokinetics AZD1981
Asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 22, 2014