HealthyPhase 1NCT01037504
AZD5423 Multiple Ascending Dose Study
A Phase 1 study testing AZD5423 in people with Healthy, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
The aim of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD5423 following multiple ascending dose administrations in healthy male and female subjects Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- AZD5423
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2010to Apr 2010
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of signed and dated, written informed consent prior to any study specific procedures
- Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
Who cannot join
- Any clinically significant disease or disorder
- Any clinically significant abnormalities at screening examination
- Use of any prescribed or non-prescribed medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Inhaled AZD5423 After Administration of Multiple Ascending Doses for 14 Days in Healthy Male and Female Subjects
The aim of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD5423 following multiple ascending dose administrations in healthy male and female subjects
- Conditions
- Healthy
- Being tested
- AZD5423, Placebo
- Keywords
- safety, tolerability, healthy, inhalation, Healthy volunteers
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD5423Drug
Suspension for nebulisation, inhaled. Each subject will receive an inhaled dose of AZD5423 or placebo once daily for 14 days. Starting dose as determined from SAD study and with up to 4 dose escalations not exceeding AstraZeneca pre-defined exposure limits.
PlaceboDrug
Solution for nebulisation, inhaled. Each subject will receive an inhaled dose of AZD5423 or placebo once daily for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Drug: AZD5423 Receives: Drug: AZD5423 |
| B | Placebo comparator | Drug: Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety variables: adverse events
Measured: Assessment taken at screening visit, defined timepoints pre-dose and post-dose during treatment periods and follow-up visit. Volunteers will be monitored throughout the study for adverse events.
Secondary outcomes (2)
Pharmacokinetics profile: concentration of AZD5423 in plasma
Measured: Samples taken at defined timepoints pre-dose and post-dose during treatment periods. Samples taken at approx. 39 timepoints.
Investigation of PD effects
Measured: Samples taken at screening visit, defined timepoints pre-dose and post-dose during treatment periods and follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionApr 2010
- Study completionApr 2010
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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Darren Wilbraham, Principal investigator, Quintiles Drug Research Unit at Guy's Hospital, London, UKJorup Carin, Study director, AstraZeneca R&D, Lund, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01037504
- Sponsor's protocol ID
- D2340C00002
- Other IDs
- EudraCT No: 2009-016611-38
- Status last verified
- Jan 2015
- First submitted
- 20 Dec 2009
- Last updated
- 14 Jan 2015
- Results posted
- No
- Data monitoring committee
- 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
- Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Inhaled AZD5423 After Administration of Multiple Ascending Doses for 14 Days in Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT01037504
- Acronym / sponsor ID
- D2340C00002
- Conditions
- Healthy
- Keywords
- safety, tolerability, healthy, inhalation, Healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 23 Dec 2009 (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 aim of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD5423 following multiple ascending dose administrations in healthy male and female subjects
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: AZD5423Drug: AZD5423 |
| B | Placebo comparator | Drug: PlaceboDrug: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Provision of signed and dated, written informed consent prior to any study specific procedures
- Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
Key exclusion criteria (3 listed)
- Any clinically significant disease or disorder
- Any clinically significant abnormalities at screening examination
- Use of any prescribed or non-prescribed medication
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 |
|---|---|---|
| AZD5423Suspension for nebulisation, inhaled. Each subject will receive an inhaled dose of AZD5423 or placebo once daily for 14 days. Starting dose as determined from SAD study and with up to 4 dose escalations not exceeding AstraZeneca pre-defined exposure limits. | Drug | A |
| PlaceboSolution for nebulisation, inhaled. Each subject will receive an inhaled dose of AZD5423 or placebo once daily for 14 days. | Drug | B |
Primary outcome
Safety variables: adverse events
Time frame: Assessment taken at screening visit, defined timepoints pre-dose and post-dose during treatment periods and follow-up visit. Volunteers will be monitored throughout the study for adverse events.
2 secondary outcomes
Pharmacokinetics profile: concentration of AZD5423 in plasma
Time frame: Samples taken at defined timepoints pre-dose and post-dose during treatment periods. Samples taken at approx. 39 timepoints.
Investigation of PD effects
Time frame: Samples taken at screening visit, defined timepoints pre-dose and post-dose during treatment periods and 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.
Related trials for Healthy
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Active, not recruitingPhase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body of Healthy Adults
Healthy
Not yet recruitingObservational study
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Blood Donors, Apheresis
Recruiting
Metabolic Impact of VLCPUFA-Rich Fish Oil: A Clinical Study on Omega-3 Index Enhancement in Healthy Individuals
Fatty Acids, Omega-3, Fish Oils
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 principal investigator
Quintiles Drug Research Unit at Guy's Hospital, London, UK
Jorup Carin study director
AstraZeneca R&D, Lund, 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 Healthy, 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 2 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. Some participants in this study may receive a placebo. 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?
Safety variables: adverse events (time frame: Assessment taken at screening visit, defined timepoints pre-dose and post-dose during treatment periods and follow-up visit. Volunteers will be monitored throughout the study for adverse events.). 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.