HealthyPhase 1NCT01310322
A Study in Healthy Subjects and Mild Asthmatics to Investigate Pharmacokinetics of AZD5423 When Administered in Different Ways
A Phase 1 study testing AZD5423 in people with Healthy and Asthma, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
A study in healthy subjects and mild asthmatics to investigate Pharmacokinetics of AZD5423 when administered in different ways. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- 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
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2011to Oct 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 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male healthy subjects and male asthma patients aged 18 to 45 years (inclusive)
- Have a body mass index (BMI) between 18 and 30 kg/m2 (inclusive and rounding allowed) and weight between 50 and 100 kg (inclusive)
- Be able to inhale from the SPIRA nebuliser and I-neb® according to the provided instructions
- Asthma patients should fulfil the following criteria: Pre-bronchodilator forced expiratory volume at 1 second (FEV1) ≥70% of predicted normal value
- Asthma diagnosis according to GINA guidelines with a history of episodic wheeze and shortness of breath
Who cannot join
- History of any clinically significant disease or disorder
- Any clinically relevant abnormal findings
- Current smokers
- Asthma patients: Worsening of asthma or respiratory infection within 6 weeks before screening
- Asthma patients: Use of inhaled, nasal, oral, rectal or parenteral corticosteroids within 30 days before first administration of investigational product and during the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open, Partly Randomised, Four-way Cross-over Study in Healthy Subjects and in Patients With Mild Allergic Asthma to Investigate the Bioavailability and Basic Pharmacokinetics of a Single Dose of AZD5423 When Administered Intravenously, Orally, Inhaled Via SPIRA Nebuliser or Inhaled Via I-neb® AAD Systems
A study in healthy subjects and mild asthmatics to investigate Pharmacokinetics of AZD5423 when administered in different ways.
- Being tested
- AZD5423
- Keywords
- Phase I, Healthy male volunteers, mild asthmatics, pharmacokinetics, Bioavailability and AUC, Level of AZD5423 in your blood
- Medical subject headings
- Asthma
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 250µg 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
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of AZD5423 measured by: Absolute bioavailability (F)
Measured: Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period
Pharmacokinetics of AZD5423 measured by: Pulmonary bioavailability (Fpulmonary)
Measured: Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period
Pharmacokinetics of AZD5423 measured by: Oral bioavailability after inhaled treatments (Foral)
Measured: Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period
Pharmacokinetics of AZD5423 measured by: Area under the plasma concentration-time curve from time zero to infinity (AUC).
Measured: Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period
Secondary outcomes (2)
To compare the pharmacokinetics between healthy subjects and asthma patients and estimate the basic pharmacokinetic parameters of AZD5423 by measuring e.g. maximum plasma concentration, Cmax
Measured: Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period
To evaluate the safety and tolerability of AZD5423 measured by adverse events, laboratory variables, physical examination, electrocardiograms, blood pressure and pulse, and spirometry.
To evaluate the safety and tolerability of AZD5423 measured by (Adverse events) (Laboratory variables) (Physical examination) (Electrocardiograms) (blood pressure and pulse) (Spirometry)
Measured: From screening to follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Darren Wilbraham, Dr, Principal investigator, Quintiles Drug Research Unit at Guy's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01310322
- Sponsor's protocol ID
- D2340C00008
- Status last verified
- Jan 2015
- First submitted
- 17 Feb 2011
- 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
- An Open, Partly Randomised, Four-way Cross-over Study in Healthy Subjects and in Patients With Mild Allergic Asthma to Investigate the Bioavailability and Basic Pharmacokinetics of a Single Dose of AZD5423 When Administered Intravenously, Orally, Inhaled Via SPIRA Nebuliser or Inhaled Via I-neb® AAD Systems
- ClinicalTrials.gov ID
- NCT01310322
- Acronym / sponsor ID
- D2340C00008
- Keywords
- Phase I, Healthy male volunteers, mild asthmatics, pharmacokinetics, Bioavailability and AUC, Level of AZD5423 in your blood
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 8 Mar 2011 (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.
A study in healthy subjects and mild asthmatics to investigate Pharmacokinetics of AZD5423 when administered in different ways.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male healthy subjects and male asthma patients aged 18 to 45 years (inclusive)
- Have a body mass index (BMI) between 18 and 30 kg/m2 (inclusive and rounding allowed) and weight between 50 and 100 kg (inclusive)
- Be able to inhale from the SPIRA nebuliser and I-neb® according to the provided instructions
- Asthma patients should fulfil the following criteria: Pre-bronchodilator forced expiratory volume at 1 second (FEV1) ≥70% of predicted normal value
- Asthma diagnosis according to GINA guidelines with a history of episodic wheeze and shortness of breath
Key exclusion criteria (5 listed)
- History of any clinically significant disease or disorder
- Any clinically relevant abnormal findings
- Current smokers
- Asthma patients: Worsening of asthma or respiratory infection within 6 weeks before screening
- Asthma patients: Use of inhaled, nasal, oral, rectal or parenteral corticosteroids within 30 days before first administration of investigational product and during 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 |
|---|---|---|
| AZD5423solution for injection, administered as intravenous infusion Corr to total dose of 250µg 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 |
Primary outcome
Pharmacokinetics of AZD5423 measured by: Absolute bioavailability (F)
Time frame: Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period
Pharmacokinetics of AZD5423 measured by: Pulmonary bioavailability (Fpulmonary)
Time frame: Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period
Pharmacokinetics of AZD5423 measured by: Oral bioavailability after inhaled treatments (Foral)
Time frame: Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period
Pharmacokinetics of AZD5423 measured by: Area under the plasma concentration-time curve from time zero to infinity (AUC).
Time frame: Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period
2 secondary outcomes
To compare the pharmacokinetics between healthy subjects and asthma patients and estimate the basic pharmacokinetic parameters of AZD5423 by measuring e.g. maximum plasma concentration, Cmax
Time frame: Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period
To evaluate the safety and tolerability of AZD5423 measured by adverse events, laboratory variables, physical examination, electrocardiograms, blood pressure and pulse, and spirometry.
Time frame: From screening to follow-up
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.
Darren Wilbraham, Dr principal investigator
Quintiles Drug Research Unit at Guy's Hospital
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 Healthy and Asthma, 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 5 inclusion and 5 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 measured by: Absolute bioavailability (F) (time frame: Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period). The study lists 4 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 14 Jan 2015.