Bioavailability and AUCPhase 1NCT01635985
A Study in Healthy Subjects to Investigate Pharmacokinetics of AZD5423 When Administered in Different Ways
A Phase 1 study testing AZD5423 in people with Bioavailability and AUC, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
The purpose of this study is to look at drug levels of AZD5423 in blood when the drug is administered in different ways - orally, intravenously or inhaled (with four different devices), to healthy subjects Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Bioavailability and AUC
- What is being tested?
- AZD5423
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2012to Dec 2012
- 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 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or women of non-childbearing potential aged 18-45 years inclusive with suitable veins for cannulation or repeated vein puncture
- Have a body mass index (BMI) between 19 and 30 kg/m2 (inclusive and rounding allowed) and weight between 50 and 100 kg (inclusive)
- Be able to inhale from the inhaler devices used in the study according to given instructions as well as be able to perform spirometry
Who cannot join
- History of any clinically significant disease or disorder
- Current smokers
- Any clinically relevant abnormal findings
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Single Centre, Open, Partly Randomised, Crossover Study in Healthy Subjects to Evaluate AZD5423 Absolute Pulmonary Bioavailability When Administered Inhaled Via a New Dry Powder Inhaler, Turbuhaler, Spira Nebulizer and I-neb AAD System
The purpose of this study is to look at drug levels of AZD5423 in blood when the drug is administered in different ways - orally, intravenously or inhaled (with four different devices), to healthy subjects
Read the detailed description
A Phase I, Single Centre, Open, Partly Randomised, Crossover Study in Healthy Subjects to Evaluate AZD5423 Absolute Pulmonary Bioavailability when Administered Inhaled via a New Dry Powder Inhaler, Turbuhaler, Spira nebulizer and I-neb AAD system
- Conditions
- Bioavailability and AUC
- Being tested
- AZD5423
- Keywords
- Phase I, Healthy male volunteers, pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD5423Drug
solution for injection, administered as intravenous infusion Corr to total dose of 250 µg AZD5423
AZD5423Drug
nebuliser suspension, inhaled via Spira, corr to approximately 300 µg lung deposited dose AZD5423
AZD5423Drug
nebuliser suspension, inhaled via I-neb, corr to approximately 300 µg lung deposited dose AZD5423
AZD5423Drug
nebuliser suspension to be administered orally, corr to a total dose of 1200 µg AZD5423
AZD5423Drug
dry powder inhaled via Turbuhaler, corr to approximately 200 µg lung deposited dose AZD5423
AZD5423Drug
dry powder inhaled via New Dry Powder Inhaler, corr to approximately 200 µg lung deposited dose AZD5423
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | AZD5423 iv Receives: Drug: AZD5423 |
| 2 | Experimental | AZD5423 inhalation, Spira Receives: Drug: AZD5423 |
| 3 | Experimental | AZD5423 inhalation I-neb Receives: Drug: AZD5423 |
| 4 | Experimental | AZD5423 oral Receives: Drug: AZD5423 |
| 5 | Experimental | AZD5423 inhalation Turbuhaler Receives: Drug: AZD5423 |
| 6 | Experimental | AZD5423, New Dry Powder Inhaler Receives: Drug: AZD5423 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of AZD5423 delivered by the new dry powder inhaler in terms of: Fpulmonary
Measured: Blood samples taken pre-dose and at10, 20 and 40 minutes and 1, 1.5, 2, 4, 6, 8, 12,16, 24, 36, 48 and 96 hours post dose.
Secondary outcomes (4)
Pharmacokinetics of AZD5423 following i.v administration in terms of : AUC, AUC(0-t), Fpo, Finhalation total, Fpulmonary, Foral, Frel, Frel Cmax, Cmax, Cmax(tmax), t½λz, MAT, MRT, Vz and Vss
Measured: Blood samples taken pre-dose and at 5, 10, 25, 30, 35 and 45 minutes and 1, 1.5, 2, 4, 6, 8, 12,16, 24, 36, 48, 72 and 96 hours post dose.
Pharmacokinetics of AZD5423 following oral administration in terms of : AUC, AUC(0-t), Fpo, Finhalation total, Fpulmonary, Foral, Frel, Frel Cmax, Cmax, Cmax(tmax), t½λz, MAT, MRT, Vz and Vss
Measured: Blood samples taken pre-dose and at10, 20 and 40 minutes and 1, 1.5, 2, 4, 6, 8, 12,16, 24, 36 and 48 hours post dose.
Pharmacokinetics of AZD5423 following oral inhalation by Spira, I-neb, Turbuhaler and New Dry Powder Inhaler in terms of : AUC, AUC(0-t), Fpo, Finhalation total, Fpulmonary, Foral, Frel, Frel Cmax, Cmax, Cmax(tmax), t½λz, MAT, MRT, Vz and Vss
Measured: Blood samples taken pre-dose and at10, 20 and 40 minutes and 1, 1.5, 2, 4, 6, 8, 12,16, 24, 36, 48 and 96 hours post dose.
Safety profile in terms of adverse events, ECG, heart rate, blood pressure, pulse rate, body temperature, physical examination, spirometry, haematology, clinical chemistry and urinalysis.
No formal statistical tests will be performed.
Measured: Screening to 28 days post dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2012 (estimated)
- Study startAug 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bioavailability and AUCStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carin Jorup, MD, Study director, AstraZeneca R&D, Molndal Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01635985
- Sponsor's protocol ID
- D2340C00012
- Other IDs
- Eudract 2012-002307-17
- Status last verified
- Jan 2015
- First submitted
- 5 Jul 2012
- Last updated
- 14 Jan 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single Centre, Open, Partly Randomised, Crossover Study in Healthy Subjects to Evaluate AZD5423 Absolute Pulmonary Bioavailability When Administered Inhaled Via a New Dry Powder Inhaler, Turbuhaler, Spira Nebulizer and I-neb AAD System
- ClinicalTrials.gov ID
- NCT01635985
- Acronym / sponsor ID
- D2340C00012
- Conditions
- Bioavailability and AUC
- Keywords
- Phase I, Healthy male volunteers, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 10 Jul 2012 (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 look at drug levels of AZD5423 in blood when the drug is administered in different ways - orally, intravenously or inhaled (with four different devices), to healthy subjects
Detailed description
A Phase I, Single Centre, Open, Partly Randomised, Crossover Study in Healthy Subjects to Evaluate AZD5423 Absolute Pulmonary Bioavailability when Administered Inhaled via a New Dry Powder Inhaler, Turbuhaler, Spira nebulizer and I-neb AAD system
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD5423AZD5423 iv |
| 2 | Experimental | Drug: AZD5423AZD5423 inhalation, Spira |
| 3 | Experimental | Drug: AZD5423AZD5423 inhalation I-neb |
| 4 | Experimental | Drug: AZD5423AZD5423 oral |
| 5 | Experimental | Drug: AZD5423AZD5423 inhalation Turbuhaler |
| 6 | Experimental | Drug: AZD5423AZD5423, New Dry Powder Inhaler |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male or women of non-childbearing potential aged 18-45 years inclusive with suitable veins for cannulation or repeated vein puncture
- Have a body mass index (BMI) between 19 and 30 kg/m2 (inclusive and rounding allowed) and weight between 50 and 100 kg (inclusive)
- Be able to inhale from the inhaler devices used in the study according to given instructions as well as be able to perform spirometry
Key exclusion criteria (3 listed)
- History of any clinically significant disease or disorder
- Current smokers
- Any clinically relevant abnormal findings
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 |
|---|---|---|
| AZD5423solution for injection, administered as intravenous infusion Corr to total dose of 250 µg AZD5423 | Drug | 1 |
| AZD5423nebuliser suspension, inhaled via Spira, corr to approximately 300 µg lung deposited dose AZD5423 | Drug | 2 |
| AZD5423nebuliser suspension, inhaled via I-neb, corr to approximately 300 µg lung deposited dose AZD5423 | Drug | 3 |
| AZD5423nebuliser suspension to be administered orally, corr to a total dose of 1200 µg AZD5423 | Drug | 4 |
| AZD5423dry powder inhaled via Turbuhaler, corr to approximately 200 µg lung deposited dose AZD5423 | Drug | 5 |
| AZD5423dry powder inhaled via New Dry Powder Inhaler, corr to approximately 200 µg lung deposited dose AZD5423 | Drug | 6 |
Primary outcome
Pharmacokinetics of AZD5423 delivered by the new dry powder inhaler in terms of: Fpulmonary
Time frame: Blood samples taken pre-dose and at10, 20 and 40 minutes and 1, 1.5, 2, 4, 6, 8, 12,16, 24, 36, 48 and 96 hours post dose.
4 secondary outcomes
Pharmacokinetics of AZD5423 following i.v administration in terms of : AUC, AUC(0-t), Fpo, Finhalation total, Fpulmonary, Foral, Frel, Frel Cmax, Cmax, Cmax(tmax), t½λz, MAT, MRT, Vz and Vss
Time frame: Blood samples taken pre-dose and at 5, 10, 25, 30, 35 and 45 minutes and 1, 1.5, 2, 4, 6, 8, 12,16, 24, 36, 48, 72 and 96 hours post dose.
Pharmacokinetics of AZD5423 following oral administration in terms of : AUC, AUC(0-t), Fpo, Finhalation total, Fpulmonary, Foral, Frel, Frel Cmax, Cmax, Cmax(tmax), t½λz, MAT, MRT, Vz and Vss
Time frame: Blood samples taken pre-dose and at10, 20 and 40 minutes and 1, 1.5, 2, 4, 6, 8, 12,16, 24, 36 and 48 hours post dose.
Pharmacokinetics of AZD5423 following oral inhalation by Spira, I-neb, Turbuhaler and New Dry Powder Inhaler in terms of : AUC, AUC(0-t), Fpo, Finhalation total, Fpulmonary, Foral, Frel, Frel Cmax, Cmax, Cmax(tmax), t½λz, MAT, MRT, Vz and Vss
Time frame: Blood samples taken pre-dose and at10, 20 and 40 minutes and 1, 1.5, 2, 4, 6, 8, 12,16, 24, 36, 48 and 96 hours post dose.
Safety profile in terms of adverse events, ECG, heart rate, blood pressure, pulse rate, body temperature, physical examination, spirometry, haematology, clinical chemistry and urinalysis.
Time frame: Screening to 28 days post dose.
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 14 Jan 2015.
- CSR SynopsisLink provided by the sponsor.
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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.
Carin Jorup, MD study director
AstraZeneca R&D, Molndal Sweden
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 AZD5423 in people with Bioavailability and AUC, run by AstraZeneca at 1 site in United Kingdom.
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 3 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 14 Jan 2015. 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 United Kingdom. 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?
Pharmacokinetics of AZD5423 delivered by the new dry powder inhaler in terms of: Fpulmonary (time frame: Blood samples taken pre-dose and at10, 20 and 40 minutes and 1, 1.5, 2, 4, 6, 8, 12,16, 24, 36, 48 and 96 hours post dose.). 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 14 Jan 2015.