Type 2 Diabetes MellitusPhase 1NCT00908271
Study of the Absolute Oral Bioavailability of Dapagliflozin in Healthy Subjects
A Phase 1 study testing Dapagliflozin in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 1 site in United States.
Trial summary
The purpose of this study is to estimate the absolute oral bioavailability of dapagliflozin. 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?
- Dapagliflozin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Aug 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 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects (ages 18 to 45) as determined by medical history, physical examination, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations will be eligible to participate in the study
Who cannot join
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations
- Participation in a radiolabeled investigational study drug trial within 12 months prior to admission to the clinical facility
- Exposure to significant radiation within 12 months prior to admission to the clinical facility
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Research Unit, Inc.
Madison, Wisconsin, 53704
About this study
The purpose of this study is to estimate the absolute oral bioavailability of dapagliflozin.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Dapagliflozin
- 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.
DapagliflozinDrug
Tablet and IV solution, Oral and IV, 10 mg po and 100 µg IV, Single oral dose followed by a single IV dose (IV dose administered at 1h after oral dose), 1 day
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin | Other | PO and IV Receives: Drug: Dapagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute oral bioavailability
Measured: Within the 3 days after study drug administration
Secondary outcomes (4)
Adverse events (AE)
Measured: Within the 3 days after study drug administration
Vital signs
Measured: Within the 3 days after study drug administration
Clinical safety labs
Measured: Within the 3 days after study drug administration
Electrocardiograms (ECGs)
Measured: Within the 3 days after study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2009 (estimated)
- Study startJul 2009
- Primary completionAug 2009
- Study completionAug 2009
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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00908271
- Sponsor's protocol ID
- MB102-059
- Status last verified
- Oct 2016
- First submitted
- 22 May 2009
- Last updated
- 17 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Absolute Oral Bioavailability of Dapagliflozin in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00908271
- Acronym / sponsor ID
- MB102-059
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Study start
- Jul 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 25 May 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.
The purpose of this study is to estimate the absolute oral bioavailability of dapagliflozin.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin | Other | Drug: DapagliflozinPO and IV |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male subjects (ages 18 to 45) as determined by medical history, physical examination, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations will be eligible to participate in the study
Key exclusion criteria (3 listed)
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations
- Participation in a radiolabeled investigational study drug trial within 12 months prior to admission to the clinical facility
- Exposure to significant radiation within 12 months prior to admission to the clinical facility
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 |
|---|---|---|
| DapagliflozinTablet and IV solution, Oral and IV, 10 mg po and 100 µg IV, Single oral dose followed by a single IV dose (IV dose administered at 1h after oral dose), 1 day | Drug | Dapagliflozin |
Primary outcome
Absolute oral bioavailability
Time frame: Within the 3 days after study drug administration
4 secondary outcomes
Adverse events (AE)
Time frame: Within the 3 days after study drug administration
Vital signs
Time frame: Within the 3 days after study drug administration
Clinical safety labs
Time frame: Within the 3 days after study drug administration
Electrocardiograms (ECGs)
Time frame: Within the 3 days after study drug administration
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 17 Oct 2016.
- MB102-059\_redacted \_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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
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 Dapagliflozin in people with Type 2 Diabetes Mellitus, 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 1 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 17 Oct 2016. 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?
Absolute oral bioavailability (time frame: Within the 3 days after study drug administration). 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 17 Oct 2016.