HealthyPhase 1NCT00984880
Study to Assess the Safety, Tolerability, 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
The primary purpose of this study is to assess the safety and tolerability of AZD3043 following administration of single ascending bolus doses (Part A) and single ascending bolus doses followed by infusion (Part B). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy 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
- 72 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2009to Dec 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects with suitable veins for cannulation or repeated venepuncture
- Pre-dose assessment judged without remarks by the investigator
- 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
- Abnormal vital signs, after 15 minutes supine rest, defined as any of the following:
- Systolic blood pressure >140 mm Hg
- Diastolic blood pressure >90 mm Hg
- Heart rate ≤45 or >85 beats per minute
- Lack of normal phenotype for BuChE (Butyrylcholinesterase)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I, Single Centre, Open Label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous AZD3043 After a Single Ascending Bolus Dose, and a Single Ascending Bolus Dose Followed by a Single Infusion Dose in Healthy Volunteers
The primary purpose of this study is to assess the safety and tolerability of AZD3043 following administration of single ascending bolus doses (Part A) and single ascending bolus doses followed by infusion (Part B).
- Conditions
- Healthy
- Being tested
- AZD3043
- Keywords
- Sedation, anaesthesia, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD3043Drug
Intravenous solution given as bolus dose (part A) and as bolus dose followed by infusion (part B)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Intravenous solution given as a single ascending bolus dose Receives: Drug: AZD3043 |
| 2 | Experimental | Intravenous solution given as a single ascending bolus dose followed by a single infusion 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, ECG
Measured: The measure will be taken between -20 to 120 min relative to stop of administration of AZD3043
Respiratory signs data (SpO2, EtCO2, PaO2, blood gases, respiratory frequency and pattern, occurrence of apnoea)
Measured: The measure will be taken between -20 to 120 min relative to stop of administration of AZD3043
Secondary outcomes (2)
PK parameters for AZD3043: Cmax (in part B: bolus Cmax and infusion Cmax), AUClast, AUC, lz, t½lz, CL, Vc, Vss, Vz, tmax, tlast and MRT arterial and venous plasma.
Measured: Part A: Arterial: Predose and continously up to 120 min after start of dosing. Part B: Arterial: Predose and continously up to 150 min after start of dosing. Venous: Predose and continously up to 24 h after start of dosing
PK parameters for the metabolite (THRX 108893): Cmax (in part B: bolus Cmax and infusion Cmax), AUClast, AUC, tmax, tlast, lz and t½lz in arterial and venous plasma.
Measured: Part A: Arterial: Predose and continously up to 120 min after start of dosing. Part B: Arterial: Predose and continously up to 150 min after start of dosing. Venous: Predose and continously up to 24 h after start of dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2009 (estimated)
- Study startSep 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Johan Wemer, Study chair, AstraZenecaSigridur Kalman, Principal investigator, Karolinska University HospitalStephen Kanes, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00984880
- Sponsor's protocol ID
- D0510C00002
- Other IDs
- Eudract number: 2008-005836-34
- Status last verified
- Dec 2009
- First submitted
- 24 Sep 2009
- Last updated
- 18 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Norberg A, Koch P, Kanes SJ, Bjornsson MA, Barassin S, Ahlen K, Kalman S. A Bolus and Bolus Followed by Infusion Study of AZD3043, an Investigational Intravenous Drug for Sedation and Anesthesia: Safety and Pharmacodynamics in Healthy Male and Female Volunteers. Anesth Analg. 2015 Oct;121(4):894-903. doi: 10.1213/ANE.0000000000000804.
PubMed 26097986
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Single Centre, Open Label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous AZD3043 After a Single Ascending Bolus Dose, and a Single Ascending Bolus Dose Followed by a Single Infusion Dose in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00984880
- Acronym / sponsor ID
- D0510C00002
- Conditions
- Healthy
- Keywords
- Sedation, anaesthesia, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Study completion
- Dec 2009 (actual)
- First posted
- 25 Sep 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 primary purpose of this study is to assess the safety and tolerability of AZD3043 following administration of single ascending bolus doses (Part A) and single ascending bolus doses followed by infusion (Part B).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD3043Intravenous solution given as a single ascending bolus dose |
| 2 | Experimental | Drug: AZD3043Intravenous solution given as a single ascending bolus dose followed by a single infusion |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects with suitable veins for cannulation or repeated venepuncture
- Pre-dose assessment judged without remarks by the investigator
- 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 (5 listed)
- Abnormal vital signs, after 15 minutes supine rest, defined as any of the following:
- Systolic blood pressure >140 mm Hg
- Diastolic blood pressure >90 mm Hg
- Heart rate ≤45 or >85 beats per minute
- Lack of normal phenotype for BuChE (Butyrylcholinesterase)
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 as bolus dose (part A) and as bolus dose followed by infusion (part B) | Drug | 1, 2 |
Primary outcome
Assessment of vital signs data, heart rate, ECG
Time frame: The measure will be taken between -20 to 120 min relative to stop of administration of AZD3043
Respiratory signs data (SpO2, EtCO2, PaO2, blood gases, respiratory frequency and pattern, occurrence of apnoea)
Time frame: The measure will be taken between -20 to 120 min relative to stop of administration of AZD3043
2 secondary outcomes
PK parameters for AZD3043: Cmax (in part B: bolus Cmax and infusion Cmax), AUClast, AUC, lz, t½lz, CL, Vc, Vss, Vz, tmax, tlast and MRT arterial and venous plasma.
Time frame: Part A: Arterial: Predose and continously up to 120 min after start of dosing. Part B: Arterial: Predose and continously up to 150 min after start of dosing. Venous: Predose and continously up to 24 h after start of dosing
PK parameters for the metabolite (THRX 108893): Cmax (in part B: bolus Cmax and infusion Cmax), AUClast, AUC, tmax, tlast, lz and t½lz in arterial and venous plasma.
Time frame: Part A: Arterial: Predose and continously up to 120 min after start of dosing. Part B: Arterial: Predose and continously up to 150 min after start of dosing. Venous: Predose and continously up to 24 h after start of 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 18 Dec 2009.
- Derived from this study: PubMed 26097986Norberg A, Koch P, Kanes SJ, Bjornsson MA, Barassin S, Ahlen K, Kalman S. A Bolus and Bolus Followed by Infusion Study of AZD3043, an Investigational Intravenous Drug for Sedation and Anesthesia: Safety and Pharmacodynamics in Healthy Male and Female Volunteers. Anesth Analg. 2015 Oct;121(4):894-903. doi: 10.1213/ANE.0000000000000804.
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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
Sigridur Kalman principal investigator
Karolinska University Hospital
Stephen Kanes study director
AstraZeneca
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 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 18 Dec 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, ECG (time frame: The measure will be taken between -20 to 120 min relative to stop 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?
On the ClinicalTrials.gov record for NCT00984880, which also lists 1 linked publication.
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 18 Dec 2009.