Type 2 Diabetes MellitusPhase 1NCT01225939
A Study Conducted Over 3 Periods to Look at the Drug in the Body
A Phase 1 study testing AZD8329 in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
A study conducted over 3 periods to look at the drug in the body. 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
- Type 2 Diabetes Mellitus
- What is being tested?
- AZD8329
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 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 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of signed and dated written informed consent before any study specific procedures including consent for genetic research exploring genetic variations in CYP3A5
- suitable veins for cannulation or repeated venepuncture
- Subjects should have a body mass index (BMI) between 18 and 30 kg/m2
Who cannot join
- Abnormal vital signs (blood pressure and pulse) after 10 minutes supine rest, as judged by the investigator
- Prolonged QTcF >450 msec or shortened QTcF <350 msec or family history of long QT syndrome
- Suspicion of known Gilbert's disease
- History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Open-label, Three-way Cross-over, Phase I Study in Healthy Subjects to Assess the Pharmacokinetics of AZD8329 After Single Doses of the Oral Solid Formulation and the Oral Solution
A study conducted over 3 periods to look at the drug in the body.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- AZD8329
- Keywords
- Type 2 diabetes mellitus, Healthy
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD8329Drug
tablet
AZD8329Drug
Solution
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Single Oral dose AZD8329 tablet (fasting) Receives: Drug: AZD8329 |
| 2 | Experimental | Single Oral dose AZD8329 solution (fasting) Receives: Drug: AZD8329 |
| 3 | Experimental | Single Oral dose AZD8329 tablet (Fed) Receives: Drug: AZD8329 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the pharmacokinetics (Cmax and AUC) of the oral solution and the oral solid formulation of AZD8329.
Measured: Information will be collected during 48h after each dose.
Secondary outcomes (2)
Explore the effect of food on the pharmacokinetics (Tmax, T1/2 and CL/F) of AZD8329 oral solid formulation.
Measured: Information will be collected during 48h after dose.
Investigate the safety and tolerability of AZD8329 administered as two different oral formulations.(Safety variables: Adverse events, Vital Signs, Clinical chemistry, Electrocardiogram (p ECG))
Measured: Adverse event will be collected from first dose to last visit . Clinical chemistry, Vital Signs and pECG's will be collected at all 5 visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2010 (estimated)
- Study startNov 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.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- J Ritter, BM BCh, MRCP, FRCP, Principal investigator, Quintiles Drug Research Unit at Guy's HospitalDr. Mirjana Kujacic, Study chair, AstraZeneca MölndalJan Eriksson, MD PhD, Study director, AstraZeneca Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01225939
- Sponsor's protocol ID
- D2350C00007
- Status last verified
- Mar 2011
- First submitted
- 20 Oct 2010
- Last updated
- 2 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Open-label, Three-way Cross-over, Phase I Study in Healthy Subjects to Assess the Pharmacokinetics of AZD8329 After Single Doses of the Oral Solid Formulation and the Oral Solution
- ClinicalTrials.gov ID
- NCT01225939
- Acronym / sponsor ID
- D2350C00007
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 diabetes mellitus, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 21 Oct 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.
A study conducted over 3 periods to look at the drug in the body.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD8329Single Oral dose AZD8329 tablet (fasting) |
| 2 | Experimental | Drug: AZD8329Single Oral dose AZD8329 solution (fasting) |
| 3 | Experimental | Drug: AZD8329Single Oral dose AZD8329 tablet (Fed) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Provision of signed and dated written informed consent before any study specific procedures including consent for genetic research exploring genetic variations in CYP3A5
- suitable veins for cannulation or repeated venepuncture
- Subjects should have a body mass index (BMI) between 18 and 30 kg/m2
Key exclusion criteria (4 listed)
- Abnormal vital signs (blood pressure and pulse) after 10 minutes supine rest, as judged by the investigator
- Prolonged QTcF >450 msec or shortened QTcF <350 msec or family history of long QT syndrome
- Suspicion of known Gilbert's disease
- History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
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 |
|---|---|---|
| AZD8329tablet | Drug | 1, 3 |
| AZD8329Solution | Drug | 2 |
Primary outcome
Compare the pharmacokinetics (Cmax and AUC) of the oral solution and the oral solid formulation of AZD8329.
Time frame: Information will be collected during 48h after each dose.
2 secondary outcomes
Explore the effect of food on the pharmacokinetics (Tmax, T1/2 and CL/F) of AZD8329 oral solid formulation.
Time frame: Information will be collected during 48h after dose.
Investigate the safety and tolerability of AZD8329 administered as two different oral formulations.(Safety variables: Adverse events, Vital Signs, Clinical chemistry, Electrocardiogram (p ECG))
Time frame: Adverse event will be collected from first dose to last visit . Clinical chemistry, Vital Signs and pECG's will be collected at all 5 visits
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 2 Mar 2011.
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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.
J Ritter, BM BCh, MRCP, FRCP principal investigator
Quintiles Drug Research Unit at Guy's Hospital
Dr. Mirjana Kujacic study chair
AstraZeneca Mölndal
Jan Eriksson, MD PhD study director
AstraZeneca 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 AZD8329 in people with Type 2 Diabetes Mellitus, 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 4 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 2 Mar 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. 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?
Compare the pharmacokinetics (Cmax and AUC) of the oral solution and the oral solid formulation of AZD8329. (time frame: Information will be collected during 48h after each dose.). 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 2 Mar 2011.