Pharmacokinetics in Adolescents

NCT01196689 | Completed Phase 1

• 1 other identifier: D9830C00021
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Asthma

Keywords

Pharmacokinetics AZD1981; Asthma

Outcome Measures

Primary Outcomes (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

  0 hours after last dose

• 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

  0.5, hours after last dose

• 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

  1 hour after last dose

• 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

  3 hours after last dose

• 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

  4 hours after last dose

• 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

  6 hours after last dose

• 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

  8 hours after last dose

• 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

  12 hours after last dose

Secondary Outcomes (2)

• Tolerability and safety assessed by adverse events

  During 7 days

• Efficacy assessed by Forced Expiratory Volume (FEV) in one second and Asthma Control Questionnaire

  Day 1 and 7

Study Arms (1)

1

EXPERIMENTAL

AZD1981 100 mg twice daily for 6 ½ days

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

Interventions

AZD1981 100 mg twice daily for 61/2 days DRUG

100 mg tablets

1

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Uppsala, Uppsala County, Sweden

Location

MeSH Terms

Conditions

Asthma

Interventions

AZD1981

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Christer Hultquist

  AstraZeneca

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 31, 2010
• First Posted: September 8, 2010
• Study Start: October 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: March 7, 2011

Record last verified: 2011-03

Locations

SE (1)