Type 1 DiabetesPhase 1NCT00817505
To Evaluate the Bioavailability of a Tablet of AZD1656
A Phase 1 study testing AZD1656 in people with Type 1 Diabetes, run by AstraZeneca at 1 site in United States.
Trial summary
To evaluate the bioavailability of a tablet of AZD1656. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- AZD1656
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Sep 2009
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, type I diabetes patients, female with non child-bearing potential.
- Treated with insulin for more than 3 years. Well controlled HbA1c.
- Have a body mass index (BMI) ≥19 and ≤35
Who cannot join
- Clinically significant illness except type I diabetes, or clinically relevant trauma, as judged by the investigator, within 2 weeks before the first administration of the investigational product
- Daily use of nicotine containing substances.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open, Single-Dose, Single-Centre, Cross-over, Phase I Study in Type 1 Diabetes Mellitus Patients to Estimate the Extent and Rate of Absorption of AZD1656 After Administration of a Tablet Formulation in the Fasting State and Just Before Food in Comparison With an Oral Suspension of AZD1
To evaluate the bioavailability of a tablet of AZD1656.
- Conditions
- Type 1 Diabetes
- Being tested
- AZD1656
- Keywords
- Type I diabetes, bioavailability
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD1656Drug
Single dose oral tablet
AZD1656Drug
Single dose oral suspension
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | AZD1656 tablet + food Receives: Drug: AZD1656 |
| 2 | Active comparator | AZD1656 susp. without food Receives: Drug: AZD1656 |
| 3 | Active comparator | AZD1656 tablet Receives: Drug: AZD1656 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic variables ( Area under the plasma concentration vs. time curve (AUC), maximum plasma concentration (Cmax), time to reach maximum plasma concentration (tmax), terminal elimination half-life (t½) and apparent oral clearance (CL/F)
Measured: Blood samples taken up to 72 hours
Secondary outcomes (2)
Pharmacodynamic variables (Plasma glucose)
Measured: Taken repeatedly during treatment periods
Safety Variables (AEs, BP, pulse, electrocardiogram (ECG), hypoglycaemic symptoms and laboratory variables)
Measured: Taken during treatment periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2009 (estimated)
- Study startDec 2008
- Primary completionMar 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies 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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Klas Malmberg, MD, PhD, Prof, Study director, AstraZeneca R&D MölndalEmanuel P DeNoia, MD, Principal investigator, Healthcare Discoveries LLC Icon Development Solutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00817505
- Sponsor's protocol ID
- D1020C00010
- Status last verified
- Nov 2009
- First submitted
- 24 Dec 2008
- Last updated
- 3 Nov 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open, Single-Dose, Single-Centre, Cross-over, Phase I Study in Type 1 Diabetes Mellitus Patients to Estimate the Extent and Rate of Absorption of AZD1656 After Administration of a Tablet Formulation in the Fasting State and Just Before Food in Comparison With an Oral Suspension of AZD1
- ClinicalTrials.gov ID
- NCT00817505
- Acronym / sponsor ID
- D1020C00010
- Conditions
- Type 1 Diabetes
- Keywords
- Type I diabetes, bioavailability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 6 Jan 2009 (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.
To evaluate the bioavailability of a tablet of AZD1656.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: AZD1656AZD1656 tablet + food |
| 2 | Active comparator | Drug: AZD1656AZD1656 susp. without food |
| 3 | Active comparator | Drug: AZD1656AZD1656 tablet |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female, type I diabetes patients, female with non child-bearing potential.
- Treated with insulin for more than 3 years. Well controlled HbA1c.
- Have a body mass index (BMI) ≥19 and ≤35
Key exclusion criteria (2 listed)
- Clinically significant illness except type I diabetes, or clinically relevant trauma, as judged by the investigator, within 2 weeks before the first administration of the investigational product
- Daily use of nicotine containing substances.
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 |
|---|---|---|
| AZD1656Single dose oral tablet | Drug | 1, 2, 3 |
| AZD1656Single dose oral suspension | Drug | 1, 2, 3 |
Primary outcome
Pharmacokinetic variables ( Area under the plasma concentration vs. time curve (AUC), maximum plasma concentration (Cmax), time to reach maximum plasma concentration (tmax), terminal elimination half-life (t½) and apparent oral clearance (CL/F)
Time frame: Blood samples taken up to 72 hours
2 secondary outcomes
Pharmacodynamic variables (Plasma glucose)
Time frame: Taken repeatedly during treatment periods
Safety Variables (AEs, BP, pulse, electrocardiogram (ECG), hypoglycaemic symptoms and laboratory variables)
Time frame: Taken during treatment periods
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 3 Nov 2009.
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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.
Klas Malmberg, MD, PhD, Prof study director
AstraZeneca R&D Mölndal
Emanuel P DeNoia, MD principal investigator
Healthcare Discoveries LLC Icon Development Solutions
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 AZD1656 in people with Type 1 Diabetes, run by AstraZeneca at 1 site in United States.
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 2 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 3 Nov 2009. 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 States. 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?
Pharmacokinetic variables ( Area under the plasma concentration vs. time curve (AUC), maximum plasma concentration (Cmax), time to reach maximum plasma concentration (tmax), terminal elimination half-life (t½) and apparent oral clearance (CL/F) (time frame: Blood samples taken up to 72 hours). 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 3 Nov 2009.