Healthy Male and Female SubjectsPhase 1NCT00546741
Drug Interaction With Metformin
A Phase 1 study testing Dapagliflozin, Metformin and Dapagliflozin + Metformin in people with Healthy Male and Female Subjects, run by AstraZeneca at 1 site in United States.
Trial summary
The purpose of the study is to determine the effect of metformin on dapagliflozin exposure and the effect of dapagliflozin on metformin exposure in healthy volunteers. Additionally, the safety and tolerability of dapagliflozin will be assessed in the presence and absence of metformin in healthy volunteers Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Male and Female Subjects
- What is being tested?
- Dapagliflozin, Metformin and Dapagliflozin + Metformin
- 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 States
- Study dates
- Nov 2007to Feb 2008
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women, ages 18-45 with a body mass index of 18-32 kg/m2
Who cannot join
- Unwilling to use acceptable method of birth control
- current or recent (within 1 month) smoker
- abnormal liver function tests
- presence of edema
- history of diabetes mellitus
- history of heart failure or renal insufficiency
- history of chronic or recurrent urinary tract infections, or vulvovaginal mycotic infections
- history of Hepatitis C
Trial locations and contacts
1 site in 1 country.
United States1 site
Bristol-Myers Squibb Clinical Pharmacology Unit
Hamilton, New Jersey, 08690
About this study
Official title: Pharmacokinetic Drug Interaction Study With Dapagliflozin and Metformin in Healthy Subjects
The purpose of the study is to determine the effect of metformin on dapagliflozin exposure and the effect of dapagliflozin on metformin exposure in healthy volunteers. Additionally, the safety and tolerability of dapagliflozin will be assessed in the presence and absence of metformin in healthy volunteers
- Conditions
- Healthy Male and Female Subjects
- Being tested
- Dapagliflozin, Metformin, Dapagliflozin + Metformin
- Keywords
- Diabetes,NOS
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapagliflozinDrug
Tablets, Oral, 20 mg, once daily single dose
MetforminDrug
Tablets, Oral, 1000 mg, once daily, single dose
Dapagliflozin + MetforminDrug
Tablets, Oral, once daily, single dose
Dapagliflozin: 20 mg
Metformin: 1000 mg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Dapagliflozin |
| 2 | Active comparator | Not described Receives: Drug: Metformin |
| 3 | Active comparator | Not described Receives: Drug: Dapagliflozin + Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the effect of metformin on the exposure of dapagliflozin and the effect of dapagliflozin on the exposure of metformin in healthy subjects after a single dose of each treatment
Measured: measures taken daily throughout the study
Secondary outcomes (1)
To assess the safety and tolerability of dapagliflozin when administered alone or with metformin after a single dose of each treatment
Measured: measures will be taken at the beginning and end of the study, as well as 1 time every 3 days (Day -1 of each study period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2007 (estimated)
- Study startNov 2007
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male and Female SubjectsStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 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
- NCT00546741
- Sponsor's protocol ID
- MB102-026
- Status last verified
- Dec 2016
- First submitted
- 18 Oct 2007
- Last updated
- 20 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Drug Interaction Study With Dapagliflozin and Metformin in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00546741
- Acronym / sponsor ID
- MB102-026
- Conditions
- Healthy Male and Female Subjects
- Keywords
- Diabetes,NOS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Study start
- Nov 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 19 Oct 2007 (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 determine the effect of metformin on dapagliflozin exposure and the effect of dapagliflozin on metformin exposure in healthy volunteers. Additionally, the safety and tolerability of dapagliflozin will be assessed in the presence and absence of metformin in healthy volunteers
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Dapagliflozin |
| 2 | Active comparator | Drug: Metformin |
| 3 | Active comparator | Drug: Dapagliflozin + Metformin |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy men and women, ages 18-45 with a body mass index of 18-32 kg/m2
Key exclusion criteria (8 listed)
- Unwilling to use acceptable method of birth control
- current or recent (within 1 month) smoker
- abnormal liver function tests
- presence of edema
- history of diabetes mellitus
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 |
|---|---|---|
| DapagliflozinTablets, Oral, 20 mg, once daily single dose | Drug | 1 |
| MetforminTablets, Oral, 1000 mg, once daily, single dose | Drug | 2 |
| Dapagliflozin + MetforminTablets, Oral, once daily, single dose Dapagliflozin: 20 mg Metformin: 1000 mg | Drug | 3 |
Primary outcome
To determine the effect of metformin on the exposure of dapagliflozin and the effect of dapagliflozin on the exposure of metformin in healthy subjects after a single dose of each treatment
Time frame: measures taken daily throughout the study
1 secondary outcome
To assess the safety and tolerability of dapagliflozin when administered alone or with metformin after a single dose of each treatment
Time frame: measures will be taken at the beginning and end of the study, as well as 1 time every 3 days (Day -1 of each study period)
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 20 Dec 2016.
- MB102026 \_Redacted \_CSR \_synopsisLink provided by the sponsor.
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Healthy Volunteers
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, Metformin and Dapagliflozin + Metformin in people with Healthy Male and Female Subjects, 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 8 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 20 Dec 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?
To determine the effect of metformin on the exposure of dapagliflozin and the effect of dapagliflozin on the exposure of metformin in healthy subjects after a single dose of each treatment (time frame: measures taken daily throughout the study). 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 20 Dec 2016.