Butyrylcholinesterase DeficiencyPhase 1NCT01205867
Study to Investigate the Safety and Tolerability of AZD8848 in Butyrylcholinesterase Deficient Subjects
A Phase 1 study testing AZD8848 in people with Butyrylcholinesterase Deficiency, run by AstraZeneca at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate the safety and tolerability of AZD8848 in Butyrylcholinesterase deficient subjects in comparison with sex and age matched control subjects. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Butyrylcholinesterase Deficiency
- What is being tested?
- AZD8848
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2010to Jan 2012
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BChE deficient subjects: The half-live of AZD8848 in plasma should be more than 20 minutes in an in vitro screening test
- Matched control subject: The half-live of AZD8848 in plasma should be less than 2 minutes in an in vitro screening test
Who cannot join
- Any clinically relevant abnormal findings in physical examination, laboratory assessments, vital signs or ECG
- Present or medical history of cardiovascular disease which, in the opinion of the investigator, may either put subject at risk because of participation in the study or influence the result of the study or the subject's ability to participate in the study
- Family history of autoimmune disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open, Non-controlled, Non-randomised, Parallel-group Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of AZD 8848 Administered Intranasally to Male and Female Butyrylcholinesterase Deficient Subjects and to Sex and Age Matched Controls
The purpose of this study is to investigate the safety and tolerability of AZD8848 in Butyrylcholinesterase deficient subjects in comparison with sex and age matched control subjects.
Read the detailed description
An Open, Non-controlled, Non-randomised, Parallel-group Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of AZD 8848 Administered Intranasally to Male and Female Butyrylcholinesterase deficient Subjects and to Sex and Age matched Controls
- Conditions
- Butyrylcholinesterase Deficiency
- Being tested
- AZD8848
- Keywords
- Butyrylcholinesterase deficiency, tolerability, safety, AZD8848, pharmacokinetics, pharmacodynamics, BChE deficient subjects and matched control subject
- Medical subject headings
- Butyrylcholinesterase deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD8848Drug
Nasal spray solution, intranasal, single ascending doses, 1.4 - 60 μg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | AZD8848 given to BChE deficient subjects and age \& gender matched control subjects Receives: Drug: AZD8848 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability will be assessed by a panel of measurements including adverse events (AEs), vital signs, ECG, laboratory variables, physical examination, and clinical inspection of the nose
Measured: Immediately prior to administration of the IP (Day 0)
Safety and tolerability will be assessed by a panel of measurements including adverse events (AEs), vital signs, ECG, laboratory variables, physical examination, and clinical inspection of the nose
Measured: Repeated assessments during Day 1.
Safety and tolerability will be assessed by a panel of measurements including adverse events (AEs), vital signs, ECG, laboratory variables, physical examination, and clinical inspection of the nose
Measured: Repeated assessments during Day 2.
Secondary outcomes (2)
Pharmacokinetics (concentration of AZD8848 and metabolite in plasma and urine)
Measured: Prior to administration of the IP (Day 0) and repeated assessments during the first 48h.
Pharmacodynamics (IL-1Ra in plasma)
Measured: Prior to administration of the IP (Day 0) and repeated assessments during the first 48h.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionFeb 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Butyrylcholinesterase DeficiencyStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jesper Sonne, MD, Principal investigator, DanTrials ApS, Copenhagen, DenmarkSam Lindgren, MD, PhD, Study director, AstraZeneca R&D, Lund, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01205867
- Sponsor's protocol ID
- D0540C00009
- Other IDs
- EUDract No: 2010-019434-27
- Status last verified
- Aug 2015
- First submitted
- 20 Sep 2010
- Last updated
- 14 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Non-controlled, Non-randomised, Parallel-group Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of AZD 8848 Administered Intranasally to Male and Female Butyrylcholinesterase Deficient Subjects and to Sex and Age Matched Controls
- ClinicalTrials.gov ID
- NCT01205867
- Acronym / sponsor ID
- D0540C00009
- Conditions
- Butyrylcholinesterase Deficiency
- Keywords
- Butyrylcholinesterase deficiency, tolerability, safety, AZD8848, pharmacokinetics, pharmacodynamics, BChE deficient subjects and matched control subject
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 21 Sep 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 this study is to investigate the safety and tolerability of AZD8848 in Butyrylcholinesterase deficient subjects in comparison with sex and age matched control subjects.
Detailed description
An Open, Non-controlled, Non-randomised, Parallel-group Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of AZD 8848 Administered Intranasally to Male and Female Butyrylcholinesterase deficient Subjects and to Sex and Age matched Controls
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD8848AZD8848 given to BChE deficient subjects and age \& gender matched control subjects |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BChE deficient subjects: The half-live of AZD8848 in plasma should be more than 20 minutes in an in vitro screening test
- Matched control subject: The half-live of AZD8848 in plasma should be less than 2 minutes in an in vitro screening test
Key exclusion criteria (3 listed)
- Any clinically relevant abnormal findings in physical examination, laboratory assessments, vital signs or ECG
- Present or medical history of cardiovascular disease which, in the opinion of the investigator, may either put subject at risk because of participation in the study or influence the result of the study or the subject's ability to participate in the study
- Family history of autoimmune disease
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 |
|---|---|---|
| AZD8848Nasal spray solution, intranasal, single ascending doses, 1.4 - 60 μg | Drug | 1 |
Primary outcome
Safety and tolerability will be assessed by a panel of measurements including adverse events (AEs), vital signs, ECG, laboratory variables, physical examination, and clinical inspection of the nose
Time frame: Immediately prior to administration of the IP (Day 0)
Safety and tolerability will be assessed by a panel of measurements including adverse events (AEs), vital signs, ECG, laboratory variables, physical examination, and clinical inspection of the nose
Time frame: Repeated assessments during Day 1.
Safety and tolerability will be assessed by a panel of measurements including adverse events (AEs), vital signs, ECG, laboratory variables, physical examination, and clinical inspection of the nose
Time frame: Repeated assessments during Day 2.
2 secondary outcomes
Pharmacokinetics (concentration of AZD8848 and metabolite in plasma and urine)
Time frame: Prior to administration of the IP (Day 0) and repeated assessments during the first 48h.
Pharmacodynamics (IL-1Ra in plasma)
Time frame: Prior to administration of the IP (Day 0) and repeated assessments during the first 48h.
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 14 Aug 2015.
- CSR SynopsisLink provided by the sponsor.
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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.
Jesper Sonne, MD principal investigator
DanTrials ApS, Copenhagen, Denmark
Sam Lindgren, MD, PhD study director
AstraZeneca R&D, 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 AZD8848 in people with Butyrylcholinesterase Deficiency, run by AstraZeneca at 1 site in Denmark.
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 14 Aug 2015. 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 Denmark. 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?
Safety and tolerability will be assessed by a panel of measurements including adverse events (AEs), vital signs, ECG, laboratory variables, physical examination, and clinical inspection of the nose (time frame: Immediately prior to administration of the IP (Day 0)). The study lists 3 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 14 Aug 2015.