SafetyPhase 1AZD3043NCT01086813
Phase I, Single Centre, Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD3043
A Phase 1 study testing AZD3043 in people with Safety and Tolerability, run by AstraZeneca.
Trial summary
Phase I, Single Centre, Open Label Study to Assess the Safety, Tolerability,Pharmacokinetics and Pharmacodynamics of Intravenous AZD3043 after aSingle Ascending Bolus Dose Followed by a Single Infusion Dose in Elderly(=65 years) Healthy Volunteers Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety, Tolerability, Pharmacokinetics
- 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
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 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 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Pre-anaesthesia assessment judged without remarks by the investigator.
- ASA physical status category 1 to 2 (up to and including 3 depending on applicable patient category)
Who cannot join
- Lack of a normal range of enzyme activity for BuChE
- Known or suspected history of hypersensitivity to drugs with a similar chemical structure or class to AZD3043 (e.g., emulsion-based products like Diprivan,Intralipid), allergies to soybean or peanut products or any other drugs intended for use during th
- Prolonged QTcF >450 ms or shortened QTcF <350 ms or family history of long QT syndrome.
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 Followed by a Single Infusion Dose in Elderly (=65 Years) Healthy Volunteers
Phase I, Single Centre, Open Label Study to Assess the Safety, Tolerability,Pharmacokinetics and Pharmacodynamics of Intravenous AZD3043 after aSingle Ascending Bolus Dose Followed by a Single Infusion Dose in Elderly(=65 years) Healthy Volunteers
Read the detailed description
Phase I, Single Centre, Open Label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous AZD3043 after a Single Ascending Bolus Dose Followed by a Single Infusion Dose in Elderly (=65 years) Healthy Volunteers
- Conditions
- Safety, Tolerability, Pharmacokinetics, Sedation
- Being tested
- AZD3043
- Keywords
- Safety, Tolerability, Pharmacokinetics, Sedation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD3043Drug
single dose/IV, bolus over 60secs - infusion over 30 mins
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: AZD3043 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate safety and tolerability after administration of a bolus and infusion of AZD3043
Measured: Heartrate, Bloodpressure, Telemetry, ECG, EtCO2, SPO2, BIS, Respiratory frequency every minute during a 1h session
Secondary outcomes (2)
To evaluate the PK of AZD3043 and its main metabolite (THRX-108893) in venous blood samples
Measured: During 24h
To evaluate the onset, level and recovery from sedation/anaesthesia
Measured: During 24h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionApr 2010 (estimated)
- Study completionApr 2010 (estimated)
Why it stopped: The compound is being re-evaluated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SafetyStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Darren Wilbraham, Principal investigator, Quintiles Drug Research Unit at Guy's HospitalQuintiles Ltd6 Newcomen StreetLondonSE1 1YRUnited KingdomStephen Kanes, Study director, AstraZenecaBrendan Smyth, Study chair, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01086813
- Sponsor's protocol ID
- D0510C00005
- Other IDs
- AZD3043
- Acronym
- AZD3043
- Status last verified
- Dec 2012
- First submitted
- 9 Mar 2010
- Last updated
- 20 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2012. 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 Followed by a Single Infusion Dose in Elderly (=65 Years) Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01086813
- Acronym / sponsor ID
- AZD3043 / D0510C00005
- Conditions
- Safety, Tolerability, Pharmacokinetics, Sedation
- Keywords
- Safety, Tolerability, Pharmacokinetics, Sedation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The compound is being re-evaluated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Apr 2010 (estimated)
- Study completion
- Apr 2010 (estimated)
- First posted
- 15 Mar 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.
Phase I, Single Centre, Open Label Study to Assess the Safety, Tolerability,Pharmacokinetics and Pharmacodynamics of Intravenous AZD3043 after aSingle Ascending Bolus Dose Followed by a Single Infusion Dose in Elderly(=65 years) Healthy Volunteers
Detailed description
Phase I, Single Centre, Open Label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous AZD3043 after a Single Ascending Bolus Dose Followed by a Single Infusion Dose in Elderly (=65 years) Healthy Volunteers
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD3043 |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Pre-anaesthesia assessment judged without remarks by the investigator.
- ASA physical status category 1 to 2 (up to and including 3 depending on applicable patient category)
Key exclusion criteria (3 listed)
- Lack of a normal range of enzyme activity for BuChE
- Known or suspected history of hypersensitivity to drugs with a similar chemical structure or class to AZD3043 (e.g., emulsion-based products like Diprivan,Intralipid), allergies to soybean or peanut products or any other drugs intended for use during th
- Prolonged QTcF >450 ms or shortened QTcF <350 ms or family history of long QT syndrome.
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 |
|---|---|---|
| AZD3043single dose/IV, bolus over 60secs - infusion over 30 mins | Drug | 1 |
Primary outcome
To evaluate safety and tolerability after administration of a bolus and infusion of AZD3043
Time frame: Heartrate, Bloodpressure, Telemetry, ECG, EtCO2, SPO2, BIS, Respiratory frequency every minute during a 1h session
2 secondary outcomes
To evaluate the PK of AZD3043 and its main metabolite (THRX-108893) in venous blood samples
Time frame: During 24h
To evaluate the onset, level and recovery from sedation/anaesthesia
Time frame: During 24h
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2012.
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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.
Darren Wilbraham principal investigator
Quintiles Drug Research Unit at Guy's HospitalQuintiles Ltd6 Newcomen StreetLondonSE1 1YRUnited Kingdom
Stephen Kanes study director
AstraZeneca
Brendan Smyth study chair
AstraZeneca
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD3043 in people with Safety and Tolerability, run by AstraZeneca.
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: withdrawn, as of the sponsor's last update on 20 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
To evaluate safety and tolerability after administration of a bolus and infusion of AZD3043 (time frame: Heartrate, Bloodpressure, Telemetry, ECG, EtCO2, SPO2, BIS, Respiratory frequency every minute during a 1h session). 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 20 Dec 2012.