HealthyPhase 1NCT00918515
Study to Assess the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of AZD3043
A Phase 1 study testing AZD3043 in people with Healthy, run by AstraZeneca at 1 site in Sweden.
Trial summary
This is a Phase I, single centre, open label study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of intravenous AZD3043 after single ascending doses in healthy male volunteers. 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
- What is being tested?
- AZD3043
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteSweden
- Study dates
- May 2009to Aug 2009
- 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 subjects aged 18 to 45 years with suitable veins for cannulation or repeated venepuncture
- Pre-dose assessment judged without remarks by the investigator
- Have a Body Mass Index (BMI) between 19 and 30 kg/m2 and weight at least 50kg and no more than 100kg
Who cannot join
- After adequate time (at least 15 minutes) of rest in supine position, abnormal vital signs defined as any of the following:·
- Systolic blood pressure (BP) >140 mm Hg.·
- Diastolic BP >90 mm Hg.
- Heart rate <=55 or >85 beats per minute
- Subjects with compromised airway or respiratory function as evidenced by the presence of Class 3 or 4 Airway, Sleep Apnoea, Neck circumference > 16.5 inches (42 cm), Asthma, Active or recent (2 weeks) respiratory infection, or known chronic respiratory infection, or known chronic respirator
- Lack of a normal phenotype for butyrylcholinesterase (pseudo-cholinesterase)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Single-Centre, Open Label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous AZD3043 After Single Ascending Doses in Healthy Male Volunteers
This is a Phase I, single centre, open label study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of intravenous AZD3043 after single ascending doses in healthy male volunteers.
- Conditions
- Healthy
- Being tested
- AZD3043
- Keywords
- Sedation, Anaesthesia, Safety, tolerability, pharmacokinetics, pharmacodynamics, healthy male volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD3043Drug
intravenous solution given once as intravenous infusion over 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| AZD3043 | Experimental | Intravenous solution Receives: Drug: AZD3043 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Vital signs data, heart rate, electrocardiogram (ECG)
Measured: The measure will be taken between -20 to 150 min relative to start of administration of AZD3043.
Respiratory signs data (SpO2, EtCO2, PaO2, blood gases, respiratory frequency, volume and pattern, occurrence of apnoea;
Measured: The measure will be taken between -20 to 150 min relative to start of administration of AZD3043.
Secondary outcomes (2)
PK parameters for AZD3043: Cmax (Css), AUClast, AUC, lz, t½lz, CL, Vc, Vss, Vz, tlast and mean residence time in arterial and venous plasma.
Measured: Arterial: Predose, 2, 5, 15, 29, 31, 32, 35, 37, 40, 45, 60, 75, 90, 150 min postdose. Venous: Predose, 2, 5, 15, 29, 31, 32, 35, 37, 40, 45, 60, 75, 90, 150, 270 min, 8h, 24h postdose.
PK parameters for the metabolite (THRX 108893): Cmax (Css), AUClast, AUC, tmax, tlast, lz and t½lz in venous plasma
Measured: 29 min, 45 min and 150 min post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2009 (estimated)
- Study startMay 2009
- Study completionAug 2009
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Johan Wemer, Study chair, AstraZeneca R&D SödertäljeSigridur Kalman, Principal investigator, Department of Clinical Science Intervention and technology, CLINTECThe department of Anaesthosiology and Intensive care, Karolinska University hospital, Huddinge,141 86 Stockholm, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00918515
- Sponsor's protocol ID
- D0510C00001
- Other IDs
- 2007-003474-26
- Status last verified
- Aug 2009
- First submitted
- 9 Jun 2009
- Last updated
- 28 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-Centre, Open Label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous AZD3043 After Single Ascending Doses in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT00918515
- Acronym / sponsor ID
- D0510C00001
- Conditions
- Healthy
- Keywords
- Sedation, Anaesthesia, Safety, tolerability, pharmacokinetics, pharmacodynamics, healthy male volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Study completion
- Aug 2009 (actual)
- First posted
- 11 Jun 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.
This is a Phase I, single centre, open label study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of intravenous AZD3043 after single ascending doses in healthy male volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AZD3043 | Experimental | Drug: AZD3043Intravenous solution |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male subjects aged 18 to 45 years with suitable veins for cannulation or repeated venepuncture
- Pre-dose assessment judged without remarks by the investigator
- Have a Body Mass Index (BMI) between 19 and 30 kg/m2 and weight at least 50kg and no more than 100kg
Key exclusion criteria (6 listed)
- After adequate time (at least 15 minutes) of rest in supine position, abnormal vital signs defined as any of the following:·
- Systolic blood pressure (BP) >140 mm Hg.·
- Diastolic BP >90 mm Hg.
- Heart rate <=55 or >85 beats per minute
- Subjects with compromised airway or respiratory function as evidenced by the presence of Class 3 or 4 Airway, Sleep Apnoea, Neck circumference > 16.5 inches (42 cm), Asthma, Active or recent (2 weeks) respiratory infection, or known chronic respiratory infection, or known chronic respirator
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 |
|---|---|---|
| AZD3043intravenous solution given once as intravenous infusion over 30 minutes | Drug | AZD3043 |
Primary outcome
Assessment of Vital signs data, heart rate, electrocardiogram (ECG)
Time frame: The measure will be taken between -20 to 150 min relative to start of administration of AZD3043.
Respiratory signs data (SpO2, EtCO2, PaO2, blood gases, respiratory frequency, volume and pattern, occurrence of apnoea;
Time frame: The measure will be taken between -20 to 150 min relative to start of administration of AZD3043.
2 secondary outcomes
PK parameters for AZD3043: Cmax (Css), AUClast, AUC, lz, t½lz, CL, Vc, Vss, Vz, tlast and mean residence time in arterial and venous plasma.
Time frame: Arterial: Predose, 2, 5, 15, 29, 31, 32, 35, 37, 40, 45, 60, 75, 90, 150 min postdose. Venous: Predose, 2, 5, 15, 29, 31, 32, 35, 37, 40, 45, 60, 75, 90, 150, 270 min, 8h, 24h postdose.
PK parameters for the metabolite (THRX 108893): Cmax (Css), AUClast, AUC, tmax, tlast, lz and t½lz in venous plasma
Time frame: 29 min, 45 min and 150 min 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 28 Aug 2009.
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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.
Johan Wemer study chair
AstraZeneca R&D Södertälje
Sigridur Kalman principal investigator
Department of Clinical Science Intervention and technology, CLINTECThe department of Anaesthosiology and Intensive care, Karolinska University hospital, Huddinge,141 86 Stockholm, 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 AZD3043 in people with Healthy, 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 3 inclusion and 6 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 28 Aug 2009. 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. 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?
Assessment of Vital signs data, heart rate, electrocardiogram (ECG) (time frame: The measure will be taken between -20 to 150 min relative to start of administration of AZD3043.). 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 28 Aug 2009.