AsthmaPhase 1PEAKNCT01196689
Pharmacokinetics in Adolescents
A Phase 1 study testing AZD1981 100 mg twice daily for 61/2 days in people with Asthma, run by AstraZeneca at 1 site in Sweden.
Trial summary
The purpose of this study is to study pharmacokinetics in adolescents. Read more about this study
- Who is it for?
- Ages 12 to 17 years, men only
- Conditions the study is for
- Asthma
- What is being tested?
- AZD1981 100 mg twice daily for 61/2 days
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2010to Feb 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
The purpose of this study is to study pharmacokinetics in adolescents.
Read the 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.
- Conditions
- Asthma
- Being tested
- AZD1981 100 mg twice daily for 61/2 days
- Keywords
- Pharmacokinetics AZD1981, Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD1981 100 mg twice daily for 61/2 daysDrug
100 mg tablets
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | AZD1981 100 mg twice daily for 6 ½ days Receives: Drug: AZD1981 100 mg twice daily for 61/2 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 12 hours after last dose
Secondary outcomes (2)
Tolerability and safety assessed by adverse events
Measured: During 7 days
Efficacy assessed by Forced Expiratory Volume (FEV) in one second and Asthma Control Questionnaire
Measured: Day 1 and 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2010 (estimated)
- Study startOct 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Christer Hultquist, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01196689
- Sponsor's protocol ID
- D9830C00021
- Acronym
- PEAK
- Status last verified
- Mar 2011
- First submitted
- 31 Aug 2010
- Last updated
- 7 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01196689
- Acronym / sponsor ID
- PEAK / D9830C00021
- Conditions
- Asthma
- Keywords
- Pharmacokinetics AZD1981, Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 8 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD1981 100 mg twice daily for 61/2 daysAZD1981 100 mg twice daily for 6 ½ days |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD1981 100 mg twice daily for 61/2 days100 mg tablets | Drug | 1 |
Primary outcome
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
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
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
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
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
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
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
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
2 secondary outcomes
Tolerability and safety assessed by adverse events
Time frame: During 7 days
Efficacy assessed by Forced Expiratory Volume (FEV) in one second and Asthma Control Questionnaire
Time frame: Day 1 and 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christer Hultquist study director
AstraZeneca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD1981 100 mg twice daily for 61/2 days in people with Asthma, run by AstraZeneca at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2011.