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Pharmacokinetics in Adolescents (PEAK)

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ClinicalTrials.gov Identifier: NCT01196689
Recruitment Status : Completed
First Posted : September 8, 2010
Last Update Posted : March 7, 2011
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
The purpose of this study is to study pharmacokinetics in adolescents.

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2010
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: 1
AZD1981 100 mg twice daily for 6 ½ days
Drug: AZD1981 100 mg twice daily for 61/2 days
100 mg tablets




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. 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 Measures :
  1. Tolerability and safety assessed by adverse events [ Time Frame: During 7 days ]
  2. Efficacy assessed by Forced Expiratory Volume (FEV) in one second and Asthma Control Questionnaire [ Time Frame: Day 1 and 7 ]


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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01196689


Locations
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Sweden
Research Site
Uppsala, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Christer Hultquist AstraZeneca
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Responsible Party: Medical Science Director (MSD), AstraZeneca
ClinicalTrials.gov Identifier: NCT01196689    
Other Study ID Numbers: D9830C00021
First Posted: September 8, 2010    Key Record Dates
Last Update Posted: March 7, 2011
Last Verified: March 2011
Keywords provided by AstraZeneca:
Pharmacokinetics AZD1981
Asthma
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases