OverweightPhase 1AZ8329NCT01207089
To Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Administration of AZD8329
A Phase 1 study testing AZD8329 in people with Overweight and Healthy, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
The purpose of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD8329 following multiple ascending dose administrations in in overweight to obese but otherwise healthy male subjects. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight, Healthy, Male
- What is being tested?
- AZD8329
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2010to Dec 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 20 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Have a body mass index (BMI) between 27 and 35 kg/m2 and a waist circumference greater than or equal to 102cm.
- Provision of signed and dated, written informed consent prior to any study specific procedures
- Healthy male subjects aged =20 to =50 years with suitable veins for cannulation or repeated venepuncture
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.
- Fasting serum (S)-glucose =7.0 mmol/L or non-fasting S-glucose =11.1 mmol/L at screening.
- Any eating disorder or actively attempting to loose weight within 3 months prior to enrolment
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 Oral AZD8329 After Administration of Multiple Ascending Doses in Abdominally Obese But Otherwise Healthy Male Subjects
The purpose of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD8329 following multiple ascending dose administrations in in overweight 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 oral AZD8329 after Administration of Multiple Ascending Doses in Abdominally Obese but otherwise Healthy Male Subjects
- Conditions
- Overweight, Healthy, Male
- Being tested
- AZD8329, Placebo
- Keywords
- Safety, tolerability, PK, healthy, overweight, obese
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD8329Drug
AZD8329 Oral Solution 20mg/ml
PlaceboDrug
Placebo AZD8329 Oral Solution
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Drug: Placebo |
| 2 | Experimental | AZD8329 Receives: Drug: AZD8329 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety variables (adverse events).
Measured: Adverse events day -1
Safety variables (adverse events).
Measured: Adverse events will colletected entire study
Safety variables (clinical laboratory assessments).
Measured: Clinical labs day 1
Safety variables (clinical laboratory assessments).
Measured: Day 4
Safety variables (clinical laboratory assessments).
Measured: Day 8
Safety variables (clinical laboratory assessments).
Measured: Day 12
Safety variables (clinical laboratory assessments).
Measured: Clinical labs at follow up
Safety variables (adverse events)
Measured: Adverse events will colletected entire study
Safety variables (vital signs)
Measured: vital signs every hour during day 1
Safety variables (physical examination)
Measured: performed at screening
Safety variables (vital signs)
Measured: Vital Signs every hr during day 12
Safety variables (physical examination)
Measured: Performed at follow up
Safety variables (telemetry)
Measured: telemetry for 24hr. post dose day 1
Safety variables (telemetry)
Measured: telemetry for 24hr. post dose day 12
Safety variables (digital electrocardiograms (dECGs))
Measured: dECG during 5min, 13 times 24 hr after dose day 1
Safety variables (digital electrocardiograms (dECGs))
Measured: dECG during 5min, 13 times 24 hr after dose day 12
Safety variables (safety 12-lead paper electrocardiograms (pECG))
Measured: pECG at screening
Safety variables (safety 12-lead paper electrocardiograms (pECG))
Measured: pECG at follow up
Safety variables (clinical laboratory assessments).
Measured: clinical labs at screening
Safety variables (clinical laboratory assessments).
Measured: clinical labs day -3
Secondary outcomes (6)
Pharmacokinetics Plasma and urine concentrations of AZD8329 and plasma and urine pharmacokinetics parameters
Measured: Information will be collected during day -1, day 1, 2, 3 and 12
Pharmacodynamic 11-βHSD1 enzyme activity in adipose tissue
Measured: Information will be collected from the time of day -1 throuout the study
Pharmacodynamic 11-βHSD1 enzyme activity in the liver by measuring prednisolone generation
Measured: Information will be collected from day -1 to follow up
To assess the effect on insulin after multiple doses of AZD8329
Measured: Information will be collected from day -2 to follow up
To assess the effect on glucose after multiple doses of AZD8329
Measured: Information will be collected from day -2 to follow up
To assess the effect on lipid variables after multiple doses of AZD8329
Measured: Information will be collected from day -2 to follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionDec 2010
- Study completionDec 2010
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 OverweightStudies 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
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dr. Jan Eriksson, Study chair, AstraZenecaDr. Mirjana Kujacic, Study director, AstraZenecaDr. James Ritter, Principal investigator, Quintiles Drug Research Unit at Guy's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01207089
- Sponsor's protocol ID
- D2350C00010
- Acronym
- AZ8329
- Status last verified
- May 2011
- First submitted
- 14 Sep 2010
- Last updated
- 10 May 2011
- Results posted
- No
Publications
Morentin Gutierrez P, Gyte A, deSchoolmeester J, Ceuppens P, Swales J, Stacey C, Eriksson JW, Sjostrand M, Nilsson C, Leighton B. Continuous inhibition of 11beta-hydroxysteroid dehydrogenase type I in adipose tissue leads to tachyphylaxis in humans and rats but not in mice. Br J Pharmacol. 2015 Oct;172(20):4806-16. doi: 10.1111/bph.13251. Epub 2015 Oct 8.
PubMed 26218540
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2011. 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 Oral AZD8329 After Administration of Multiple Ascending Doses in Abdominally Obese But Otherwise Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01207089
- Acronym / sponsor ID
- AZ8329 / D2350C00010
- Conditions
- Overweight, Healthy, Male
- Keywords
- Safety, tolerability, PK, healthy, overweight, obese
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 22 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 the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD8329 following multiple ascending dose administrations in in overweight 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 oral AZD8329 after Administration of Multiple Ascending Doses in Abdominally Obese but otherwise Healthy Male Subjects
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: Placebo |
| 2 | Experimental | Drug: AZD8329AZD8329 |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Have a body mass index (BMI) between 27 and 35 kg/m2 and a waist circumference greater than or equal to 102cm.
- Provision of signed and dated, written informed consent prior to any study specific procedures
- Healthy male subjects aged =20 to =50 years with suitable veins for cannulation or repeated venepuncture
Key exclusion criteria (3 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.
- Fasting serum (S)-glucose =7.0 mmol/L or non-fasting S-glucose =11.1 mmol/L at screening.
- Any eating disorder or actively attempting to loose weight within 3 months prior to enrolment
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 |
|---|---|---|
| AZD8329AZD8329 Oral Solution 20mg/ml | Drug | 2 |
| PlaceboPlacebo AZD8329 Oral Solution | Drug | 1 |
Primary outcome
Safety variables (adverse events).
Time frame: Adverse events day -1
Safety variables (adverse events).
Time frame: Adverse events will colletected entire study
Safety variables (clinical laboratory assessments).
Time frame: Clinical labs day 1
Safety variables (clinical laboratory assessments).
Time frame: Day 4
Safety variables (clinical laboratory assessments).
Time frame: Day 8
Safety variables (clinical laboratory assessments).
Time frame: Day 12
Safety variables (clinical laboratory assessments).
Time frame: Clinical labs at follow up
Safety variables (adverse events)
Time frame: Adverse events will colletected entire study
Safety variables (vital signs)
Time frame: vital signs every hour during day 1
Safety variables (physical examination)
Time frame: performed at screening
Safety variables (vital signs)
Time frame: Vital Signs every hr during day 12
Safety variables (physical examination)
Time frame: Performed at follow up
Safety variables (telemetry)
Time frame: telemetry for 24hr. post dose day 1
Safety variables (telemetry)
Time frame: telemetry for 24hr. post dose day 12
Safety variables (digital electrocardiograms (dECGs))
Time frame: dECG during 5min, 13 times 24 hr after dose day 1
Safety variables (digital electrocardiograms (dECGs))
Time frame: dECG during 5min, 13 times 24 hr after dose day 12
Safety variables (safety 12-lead paper electrocardiograms (pECG))
Time frame: pECG at screening
Safety variables (safety 12-lead paper electrocardiograms (pECG))
Time frame: pECG at follow up
Safety variables (clinical laboratory assessments).
Time frame: clinical labs at screening
Safety variables (clinical laboratory assessments).
Time frame: clinical labs day -3
6 secondary outcomes
Pharmacokinetics Plasma and urine concentrations of AZD8329 and plasma and urine pharmacokinetics parameters
Time frame: Information will be collected during day -1, day 1, 2, 3 and 12
Pharmacodynamic 11-βHSD1 enzyme activity in adipose tissue
Time frame: Information will be collected from the time of day -1 throuout the study
Pharmacodynamic 11-βHSD1 enzyme activity in the liver by measuring prednisolone generation
Time frame: Information will be collected from day -1 to follow up
To assess the effect on insulin after multiple doses of AZD8329
Time frame: Information will be collected from day -2 to follow up
To assess the effect on glucose after multiple doses of AZD8329
Time frame: Information will be collected from day -2 to follow up
To assess the effect on lipid variables after multiple doses of AZD8329
Time frame: Information will be collected from day -2 to follow up
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 10 May 2011.
- Derived from this study: PubMed 26218540Morentin Gutierrez P, Gyte A, deSchoolmeester J, Ceuppens P, Swales J, Stacey C, Eriksson JW, Sjostrand M, Nilsson C, Leighton B. Continuous inhibition of 11beta-hydroxysteroid dehydrogenase type I in adipose tissue leads to tachyphylaxis in humans and rats but not in mice. Br J Pharmacol. 2015 Oct;172(20):4806-16. doi: 10.1111/bph.13251. Epub 2015 Oct 8.
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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.
Dr. Jan Eriksson study chair
AstraZeneca
Dr. Mirjana Kujacic study director
AstraZeneca
Dr. James Ritter principal investigator
Quintiles Drug Research Unit at Guy's Hospital
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 AZD8329 in people with Overweight and Healthy, 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 3 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 10 May 2011. 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 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 variables (adverse events). (time frame: Adverse events day -1). The study lists 20 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 NCT01207089, 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 10 May 2011.