ObesityPhase 1NCT01469923
To Assess the Safety, Tolerability, Pharmacokinetics and Pharmakodynamics of AZD2820 After Multiple Ascending Doses
A Phase 1 study testing AZD2820 in people with Obesity, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
This is a randomised and single-blind, placebo-controlled study to investigate the safety, tolerabilty, pharmacokinetics and pharmacodynamics of repeated and ascending doses of AZD2820 to obese but otherwise healthy male subjects. 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
- Obesity
- What is being tested?
- AZD2820
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2012to Dec 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of signed and dated, written informed consent prior to any study specific procedures including the genetic sampling and analyses
- Obese but otherwise healthy male subjects aged 18 - 45 years with suitable veins for cannulation or repeated venepuncture
- Male subjects should be willing to use barrier contraception ie, condoms, from the first day of dosing until 3 months after the last dose of investigational product
- Have a body mass index (BMI) between 27 and 40 kg/m2
Who cannot join
- History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the stud
- A history of erectile dysfunction or anatomic abnormality of the penis (eg, cavernosal fibrosis, Peyronie's disease, or plaques) which interferes with normal erectile function
- Prolonged QTcF >450 ms or shortened QTcF <340 ms or family history of long QT syndrome
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD2820
- Any clinically significant abnormalities in clinical chemistry, haematology (including eosinophilia) or urinalysis results as judged by the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Single Centre, Single-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD2820 After Administration of Multiple Ascending Doses
This is a randomised and single-blind, placebo-controlled study to investigate the safety, tolerabilty, pharmacokinetics and pharmacodynamics of repeated and ascending doses of AZD2820 to obese but otherwise healthy male subjects.
Read the detailed description
A Phase I, Single Centre, Single-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD2820 after Administration of Multiple Ascending Doses.
- Conditions
- Obesity
- Being tested
- AZD2820, Placebo
- Keywords
- Phase 1, obese, healthy male volunteers, multiple doses, dose escalation, pharmacokinetics, pharmakodynamics
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD2820Drug
Ascending subcutaneous injections of AZD2820 once daily for 14 days in the abdomen
PlaceboDrug
Ascending subcutaneous injections of placebo for AZD2820 once daily for 14 days in the abdomen
| Study group | Role | What they receive |
|---|---|---|
| AZD2820 | Active comparator | AZD2820 multiple injections Receives: Drug: AZD2820 |
| Placebo for AZD2820 | Placebo comparator | Placebo for AZD2820 multiple injections Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the safety and tolerability profile of AZD2820 in terms of adverse events.
No formal statistical test will be performed. Abnormalities will be listed without statistical analysis.
Measured: From baseline, defined as day 1 of dosing, up to day 29
Description of the safety and tolerability profile of AZD2820 in terms of labolatory data ( clinical chemistry, haematology and urinalisys).
No formal statistical test will be performed. Abnormalities will be listed without statistical analysis.
Measured: From baseline, defined as one day prior first dose, up to day 28.
Description of the safety and tolerability profile of AZD2820 in terms of vital signs ( pulse, systolic and diastolic blood preassure ( SBP, DBP and 24h ambulatory BP), body temperature).
No formal statistical test will be performed. Abnormalities will be listed without statistical analysis.
Measured: From baseline, defined as one day prior first dose, up to day 29.
Description of the safety and tolerability profile of AZD2820 in terms of total immunoglobulin levels.
Number of subjects with immunoglobuline level outsite of reference range. No formal statistical tests will be performed. Abnormalities will be listed without statistical analysis.
Measured: From baseline, defined as one day prior first dose, up to day 44.
Description of the safety and tolerability profile of AZD2820 in terms of safety electrocardiogram (ECG).
No formal statistical test will be performed. Abnormalities will be listed without statistical analysis
Measured: From baseline, defined as last pre dose measurement, up to day 28.
Description of the safety and tolerability profile of AZD2820 in terms of digital electrocardiogram (ECG).
No formal statistical test will be performed. Abnormalities will be listed without statistical analysis. The QT correction factor will be based on the Fridericia's formula.
Measured: From baseline, defined as assessment at screening visit and day 1 of dosing.
Description of the safety and tolerability profile of AZD2820 in terms of electroencephalography (EEG).
No formal statistical test will be performed. Abnormalities will be listed without statistical analysis.
Measured: From baseline, defined as mean value of the 10 minutes recording prior first dose up to 7th day of dosing.
Description of the safety and tolerability profile of AZD2820 in terms of Columbia-Suicide Severity Rating Scale (C-SSRS).
No formal statistical test will be performed. Abnormalities will be listed without statistical analysis.
Measured: From baseline, defined as one day prior first dose, up to day 12th of dosing.
Description of the safety and tolerability profile of AZD2820 in terms of skin pigmentation.
No formal statistical test will be performed.
Measured: From baseline, defined as one day before first dose, up to day 29.
Description of the safety and tolerability profile of AZD2820 in terms of Penile erection (measured by Rigiscan).
No formal statistical test will be performed.
Measured: From baseline, defined as one day before first dose, up 12th day of dosing.
Description of the safety and tolerability profile of AZD2820 in terms of physical examination.
No formal statistical test will be performed. Abnormalities will be listed without statistical analysis.
Measured: From baseline, defined as two days prior first dose, up to day 29.
Secondary outcomes (3)
Change in total caloric intake from baseline.
Change from baseline will be measured after each meal and then grafically presented.
Measured: From baseline, defined as one day prior first dose to end of treatement which is day 15.
Description of the PK profile of AZD2820 in terms of Cmax, AUC(0-tau), AUC(0-t), AUC, (t1/2lz, h).
Maximum drug plasma concentration (Cmax), Area under the drug plasma concentration-time curve from zero to the end of the dosing interval (AUC(0-tau), Area under the plasma concentration-time curve from zero to the time of the last quantifiable concentration (AUC(0-t)), Area under the plasma concentration time curve from zero to infinity (AUC), Terminal half-life (t1/2lz, h).
Measured: Day 1, PK samples collected post-dese at 20 min, 40 min, 1hr, 1.20hr, 1.40hr, 2hrs, 3hrs, 4hrs, 6hrs, 8hrs, 12hrs, 18hrs and 24hrs.
Description of PK profile of AZD2820 in terms of (Css,max, nmol/L), AUCss,(0-tau), (t1/2lz).
Maximum plasma concentration at steady state (Css,max, nmol/L), Area under the plasma concentration-time curve from zero to the end of the dosing interval at steady state (AUCss,(0-tau)), Terminal half-life (t1/2lz).
Measured: Day 7, PK samples collected post-dese at 20 min, 40 min, 1hr, 1.20hr, 1.40hr, 2hrs, 3hrs, 4hrs, 6hrs, 8hrs, 12hrs, 18hrs and 24hrs.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2011 (estimated)
- Study startMar 2012
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Ritter, BM BCH, MRCP, FRCP, Principal investigator, QLONMark Berner Hansen, PHD, Study director, AstraZeneca Mölndal, SwedenMirjana Kujacic, PHD, Study chair, AstraZeneca Mölndal, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01469923
- Sponsor's protocol ID
- D3870C00002
- Status last verified
- Jul 2012
- First submitted
- 30 Sep 2011
- Last updated
- 24 Jul 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single Centre, Single-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD2820 After Administration of Multiple Ascending Doses
- ClinicalTrials.gov ID
- NCT01469923
- Acronym / sponsor ID
- D3870C00002
- Conditions
- Obesity
- Keywords
- Phase 1, obese, healthy male volunteers, multiple doses, dose escalation, pharmacokinetics, pharmakodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 18 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 10 Nov 2011 (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 randomised and single-blind, placebo-controlled study to investigate the safety, tolerabilty, pharmacokinetics and pharmacodynamics of repeated and ascending doses of AZD2820 to obese but otherwise healthy male subjects.
Detailed description
A Phase I, Single Centre, Single-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD2820 after Administration of Multiple Ascending Doses.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AZD2820 | Active comparator | Drug: AZD2820AZD2820 multiple injections |
| Placebo for AZD2820 | Placebo comparator | Drug: PlaceboPlacebo for AZD2820 multiple injections |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Provision of signed and dated, written informed consent prior to any study specific procedures including the genetic sampling and analyses
- Obese but otherwise healthy male subjects aged 18 - 45 years with suitable veins for cannulation or repeated venepuncture
- Male subjects should be willing to use barrier contraception ie, condoms, from the first day of dosing until 3 months after the last dose of investigational product
- Have a body mass index (BMI) between 27 and 40 kg/m2
Key exclusion criteria (5 listed)
- History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the stud
- A history of erectile dysfunction or anatomic abnormality of the penis (eg, cavernosal fibrosis, Peyronie's disease, or plaques) which interferes with normal erectile function
- Prolonged QTcF >450 ms or shortened QTcF <340 ms or family history of long QT syndrome
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD2820
- Any clinically significant abnormalities in clinical chemistry, haematology (including eosinophilia) or urinalysis results as judged by the investigator
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 |
|---|---|---|
| AZD2820Ascending subcutaneous injections of AZD2820 once daily for 14 days in the abdomen | Drug | AZD2820 |
| PlaceboAscending subcutaneous injections of placebo for AZD2820 once daily for 14 days in the abdomen | Drug | Placebo for AZD2820 |
Primary outcome
Description of the safety and tolerability profile of AZD2820 in terms of adverse events.
Time frame: From baseline, defined as day 1 of dosing, up to day 29
No formal statistical test will be performed. Abnormalities will be listed without statistical analysis.
Description of the safety and tolerability profile of AZD2820 in terms of labolatory data ( clinical chemistry, haematology and urinalisys).
Time frame: From baseline, defined as one day prior first dose, up to day 28.
No formal statistical test will be performed. Abnormalities will be listed without statistical analysis.
Description of the safety and tolerability profile of AZD2820 in terms of vital signs ( pulse, systolic and diastolic blood preassure ( SBP, DBP and 24h ambulatory BP), body temperature).
Time frame: From baseline, defined as one day prior first dose, up to day 29.
No formal statistical test will be performed. Abnormalities will be listed without statistical analysis.
Description of the safety and tolerability profile of AZD2820 in terms of total immunoglobulin levels.
Time frame: From baseline, defined as one day prior first dose, up to day 44.
Number of subjects with immunoglobuline level outsite of reference range. No formal statistical tests will be performed. Abnormalities will be listed without statistical analysis.
Description of the safety and tolerability profile of AZD2820 in terms of safety electrocardiogram (ECG).
Time frame: From baseline, defined as last pre dose measurement, up to day 28.
No formal statistical test will be performed. Abnormalities will be listed without statistical analysis
Description of the safety and tolerability profile of AZD2820 in terms of digital electrocardiogram (ECG).
Time frame: From baseline, defined as assessment at screening visit and day 1 of dosing.
No formal statistical test will be performed. Abnormalities will be listed without statistical analysis. The QT correction factor will be based on the Fridericia's formula.
Description of the safety and tolerability profile of AZD2820 in terms of electroencephalography (EEG).
Time frame: From baseline, defined as mean value of the 10 minutes recording prior first dose up to 7th day of dosing.
No formal statistical test will be performed. Abnormalities will be listed without statistical analysis.
Description of the safety and tolerability profile of AZD2820 in terms of Columbia-Suicide Severity Rating Scale (C-SSRS).
Time frame: From baseline, defined as one day prior first dose, up to day 12th of dosing.
No formal statistical test will be performed. Abnormalities will be listed without statistical analysis.
Description of the safety and tolerability profile of AZD2820 in terms of skin pigmentation.
Time frame: From baseline, defined as one day before first dose, up to day 29.
No formal statistical test will be performed.
Description of the safety and tolerability profile of AZD2820 in terms of Penile erection (measured by Rigiscan).
Time frame: From baseline, defined as one day before first dose, up 12th day of dosing.
No formal statistical test will be performed.
Description of the safety and tolerability profile of AZD2820 in terms of physical examination.
Time frame: From baseline, defined as two days prior first dose, up to day 29.
No formal statistical test will be performed. Abnormalities will be listed without statistical analysis.
3 secondary outcomes
Change in total caloric intake from baseline.
Time frame: From baseline, defined as one day prior first dose to end of treatement which is day 15.
Description of the PK profile of AZD2820 in terms of Cmax, AUC(0-tau), AUC(0-t), AUC, (t1/2lz, h).
Time frame: Day 1, PK samples collected post-dese at 20 min, 40 min, 1hr, 1.20hr, 1.40hr, 2hrs, 3hrs, 4hrs, 6hrs, 8hrs, 12hrs, 18hrs and 24hrs.
Description of PK profile of AZD2820 in terms of (Css,max, nmol/L), AUCss,(0-tau), (t1/2lz).
Time frame: Day 7, PK samples collected post-dese at 20 min, 40 min, 1hr, 1.20hr, 1.40hr, 2hrs, 3hrs, 4hrs, 6hrs, 8hrs, 12hrs, 18hrs and 24hrs.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 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.
James Ritter, BM BCH, MRCP, FRCP principal investigator
QLON
Mark Berner Hansen, PHD study director
AstraZeneca Mölndal, Sweden
Mirjana Kujacic, PHD study chair
AstraZeneca Mölndal, 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 AZD2820 in people with Obesity, run by AstraZeneca at 1 site in United Kingdom.
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 4 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: stopped early, as of the sponsor's last update on 24 Jul 2012. 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 United Kingdom. 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 was stopped early. Results are not available in the source record.
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?
Description of the safety and tolerability profile of AZD2820 in terms of adverse events. (time frame: From baseline, defined as day 1 of dosing, up to day 29). The study lists 11 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 24 Jul 2012.