Healthy VolunteersPhase 1AZD3199MADNCT00713271
Multiple Ascending Doses (MAD) of AZD3199 Given Once Daily as Inhaled Formulation Via Turbuhaler to Healthy Men
A Phase 1 study testing AZD3199 in people with Healthy Volunteers, run by AstraZeneca at 1 site in Sweden.
Trial summary
The purpose of this study is to investigate the safety and tolerability of multiple once daily ascending doses of AZD3199 in healthy men 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
- Healthy Volunteers
- What is being tested?
- AZD3199
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2008to Nov 2008
- 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
- BMI 19-30, weight 60-100 kg
- Non/ex-smokers, Non/ex-nicotine users
Who cannot join
- Any clinically significant disease or disorder
- Any clinically relevant abnormal findings at screening examinations
- 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, Randomised, Double-blind, Placebo-controlled, Parallel-group, Single-centre Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of AZD3199 (a B2-agonist) Given Once Daily as Inhaled Formulation Via Turbuhaler to Healthy Men
The purpose of this study is to investigate the safety and tolerability of multiple once daily ascending doses of AZD3199 in healthy men
- Conditions
- Healthy Volunteers
- Being tested
- AZD3199, Placebo
- Keywords
- Healthy male, tolerability, safety, 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.
AZD3199Drug
Low dose
Dry powder for inhalation, o.d., 1+12 days
PlaceboDrug
AZD3199Drug
intermediate dose
Dry powder for inhalation, o.d., 1+12 days
AZD3199Drug
high dose
Dry powder for inhalation, o.d., 1+12 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Low dose Receives: Drug: AZD3199 |
| 2 | Experimental | intermediate dose Receives: Drug: AZD3199 |
| 3 | Experimental | high dose Receives: Drug: AZD3199 |
| 4 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and nature of Adverse Events
Measured: Before, during and after dosing
Clinical significant abnormalities in ECG, pulse, blood pressure, lung function, temp, lab
Measured: Before, during and after dosing
Secondary outcomes (3)
Pharmacokinetics
Measured: Before, during and after dosing
Potassium and lactate concentrations
Measured: Before, during and after dosing
Tremor, palpitations, heart rate, QTc, pulse and blood pressure and FEV1
Measured: Before, during and after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2008 (estimated)
- Study startAug 2008
- Primary completionNov 2008
- Study completionNov 2008
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gabriella Samuelsson Palmgren, Principal investigator, AZ CPU Lund, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00713271
- Sponsor's protocol ID
- D0570C00002
- Acronym
- AZD3199MAD
- Status last verified
- Apr 2014
- First submitted
- 9 Jul 2008
- Last updated
- 10 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomised, Double-blind, Placebo-controlled, Parallel-group, Single-centre Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of AZD3199 (a B2-agonist) Given Once Daily as Inhaled Formulation Via Turbuhaler to Healthy Men
- ClinicalTrials.gov ID
- NCT00713271
- Acronym / sponsor ID
- AZD3199MAD / D0570C00002
- Conditions
- Healthy Volunteers
- Keywords
- Healthy male, tolerability, safety, inhalation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 11 Jul 2008 (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 investigate the safety and tolerability of multiple once daily ascending doses of AZD3199 in healthy men
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD3199Low dose |
| 2 | Experimental | Drug: AZD3199intermediate dose |
| 3 | Experimental | Drug: AZD3199high dose |
| 4 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI 19-30, weight 60-100 kg
- Non/ex-smokers, Non/ex-nicotine users
Key exclusion criteria (3 listed)
- Any clinically significant disease or disorder
- Any clinically relevant abnormal findings at screening examinations
- 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 |
|---|---|---|
| AZD3199Low dose Dry powder for inhalation, o.d., 1+12 days | Drug | 1 |
| Placebo | Drug | 4 |
| AZD3199intermediate dose Dry powder for inhalation, o.d., 1+12 days | Drug | 2 |
| AZD3199high dose Dry powder for inhalation, o.d., 1+12 days | Drug | 3 |
Primary outcome
Incidence and nature of Adverse Events
Time frame: Before, during and after dosing
Clinical significant abnormalities in ECG, pulse, blood pressure, lung function, temp, lab
Time frame: Before, during and after dosing
3 secondary outcomes
Pharmacokinetics
Time frame: Before, during and after dosing
Potassium and lactate concentrations
Time frame: Before, during and after dosing
Tremor, palpitations, heart rate, QTc, pulse and blood pressure and FEV1
Time frame: Before, during and after dosing
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 10 Apr 2014.
- Related InfoLink provided by the sponsor.
- CSR-D0570C00002.pdfLink provided by the sponsor.
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Screening Protocol
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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.
Gabriella Samuelsson Palmgren principal investigator
AZ CPU 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 AZD3199 in people with Healthy Volunteers, 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 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 10 Apr 2014. 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. 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?
Incidence and nature of Adverse Events (time frame: Before, during and after dosing). The study lists 2 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 10 Apr 2014.