Healthy VolunteersPhase 1NCT01166698
Single Centre, Double-blind, Single and Multiple Ascending Inhaled Doses of AZD9819 in Healthy Subjects
A Phase 1 study testing AZD9819 in people with Healthy Volunteers and Safety, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
The purpose of the study is to assess safety and tolerability of AZD9819 following inhaled administration of single and multiple increasing doses, and to estimate the maximum dose that is tolerated in healthy people. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Safety, Tolerability
- What is being tested?
- AZD9819
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2010to Jan 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 50 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
- Healthy male and female (non-child bearing potential) subjects aged 18 to 50 years with suitable veins for cannulation or repeated venepuncture.
- 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: A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group, 2-part Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Inhaled Doses of AZD9819 in Healthy Subjects
The purpose of the study is to assess safety and tolerability of AZD9819 following inhaled administration of single and multiple increasing doses, and to estimate the maximum dose that is tolerated in healthy people.
- Conditions
- Healthy Volunteers, Safety, Tolerability
- Being tested
- AZD9819, Placebo
- Keywords
- Safety, tolerability, healthy, inhalation
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD9819Drug
Inhaled single doses of suspension via SPIRA nebuliser
AZD9819Drug
Also called Part B (multiple ascending doses)
Inhaled multiple doses of suspension via SPIRA nebuliser, once daily for 10 (maximum 14) days
PlaceboDrug
Also called Part A and B
Inhaled doses of suspension via SPIRA nebuliser given either as single (Part A) or multiple doses (Part B)
| Study group | Role | What they receive |
|---|---|---|
| AZD9819 | Experimental | Inhaled suspension Receives: Drug: AZD9819 |
| Placebo | Placebo comparator | Inhaled suspension Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety variables (ECG variables, adverse events, blood pressure, pulse, body temp, safety lab)
Measured: Frequent safety measurements during the study from screening period to follow-up
Secondary outcomes (1)
Pharmacokinetic variables of AZD9819 by assessment of drug concentrations in plasma
Measured: Multiple PK blood samples from pre-dose until 96 hours post last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2010 (estimated)
- Study startAug 2010
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01166698
- Sponsor's protocol ID
- D3020C00001
- Status last verified
- Nov 2011
- First submitted
- 20 Jul 2010
- Last updated
- 9 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group, 2-part Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Inhaled Doses of AZD9819 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01166698
- Acronym / sponsor ID
- D3020C00001
- Conditions
- Healthy Volunteers, Safety, Tolerability
- Keywords
- Safety, tolerability, healthy, inhalation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 21 Jul 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 the study is to assess safety and tolerability of AZD9819 following inhaled administration of single and multiple increasing doses, and to estimate the maximum dose that is tolerated in healthy people.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AZD9819 | Experimental | Drug: AZD9819Inhaled suspension |
| Placebo | Placebo comparator | Drug: PlaceboInhaled suspension |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Provision of signed and dated, written informed consent prior to any study specific procedures
- Healthy male and female (non-child bearing potential) subjects aged 18 to 50 years with suitable veins for cannulation or repeated venepuncture.
- 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 |
|---|---|---|
| AZD9819Inhaled single doses of suspension via SPIRA nebuliser | Drug | AZD9819 |
| AZD9819Also: Part B (multiple ascending doses)Inhaled multiple doses of suspension via SPIRA nebuliser, once daily for 10 (maximum 14) days | Drug | AZD9819 |
| PlaceboAlso: Part A and BInhaled doses of suspension via SPIRA nebuliser given either as single (Part A) or multiple doses (Part B) | Drug | Placebo |
Primary outcome
Safety variables (ECG variables, adverse events, blood pressure, pulse, body temp, safety lab)
Time frame: Frequent safety measurements during the study from screening period to follow-up
1 secondary outcome
Pharmacokinetic variables of AZD9819 by assessment of drug concentrations in plasma
Time frame: Multiple PK blood samples from pre-dose until 96 hours post last 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 9 Nov 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.
The record lists no contact. Use the official record to reach the sponsor.
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 AZD9819 in people with Healthy Volunteers and Safety, 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 9 Nov 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 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 (ECG variables, adverse events, blood pressure, pulse, body temp, safety lab) (time frame: Frequent safety measurements during the study from screening period to follow-up). 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 9 Nov 2011.