Type 2 Diabetes MellitusPhase 1NCT00839683
Pharmacokinetic Drug Interaction Study of Dapagliflozin and Valsartan or Simvastatin in Healthy Subjects
A Phase 1 study testing simvastatin, Dapagliflozin and valsartan in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 1 site in United States.
Trial summary
Phase A - To assess the effect of simvastatin on the pharmacokinetics (PK) of dapagliflozin and to determine the effect of dapagliflozin on the PK of simvastatin, when simvastatin and dapagliflozin are coadministered in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- simvastatin, Dapagliflozin and valsartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Mar 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
- Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive. BMI = weight (kg)/[height (m)]2
Who cannot join
- Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 12 weeks after the last dose of investigational product
- Abnormal urinalysis at screening (repeat urinalysis may be allowed for positive hematuria in women)
- Glucosuria at screening
- Abnormal liver functions tests (ALT, AST or total bilirubin > 10% above ULN)
- Presence of edema on physical exam
- History of diabetes mellitus
Show all 20Show fewer
- History of heart failure
- History of renal insufficiency
- History of chronic or recurrent UTI (defined as 3 occurrences per year) or UTI in the past 3 months
- History of recurrent (defined as 3 occurences per year) or recent vulvovaginal mycotic infections
- Positive urine screen for drugs of abuse either at screening or before dosing
- Positive blood screen for hepatitis C antibody, hepatitis C antibody, hepatitis B surface antigen, or HIV-1, -2 antibody
- History of allergy to SGLT2 inhibitors or related compounds
- History of any significant drug allergy (such as anaphylaxis or hepatotoxicity)
- History of allergy or intolerance to valsartan or simvastatin (or related compounds)
- Prior exposure to dapagliflozin, valsartan or simvastatin within 3 months of Day -1
- Exposure to any investigational drug or placebo within 4 weeks of Day -1
- Use of any prescription drugs within 4 weeks or over-the-counter acid controllers within 2 weeks prior to any study drug administration
- Use of any other drugs, including over-the counter medications within 1 week and herbal preparations within 2 weeks prior to admission to the study facility
- Use of an oral, injectable or implantable hormonal contraceptive agent within 3 months of Day -1
Trial locations and contacts
1 site in 1 country.
United States1 site
Mds Pharma Services (Us) Inc.
Neptune City, New Jersey, 07753
About this study
Phase A - To assess the effect of simvastatin on the pharmacokinetics (PK) of dapagliflozin and to determine the effect of dapagliflozin on the PK of simvastatin, when simvastatin and dapagliflozin are coadministered in healthy subjects. Phase B - To assess the effect of valsartan on the PK of dapagliflozin and to determine the effect of dapagliflozin on the PK of valsartan, when valsartan and dapagliflozin are coadministered in healthy subjects
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- simvastatin, Dapagliflozin, valsartan
- 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.
simvastatinDrug
Also called Zocor
Tablets, Oral, 20 mg, Single Dose
DapagliflozinDrug
Also called BMS-512148
Tablets, Oral, 20 mg, Single Dose
simvastatinDrug
Oral, 40 mg, Single Dose
valsartanDrug
Also called Diovan
Tablets, Oral, 320 mg, Single Dose
| Study group | Role | What they receive |
|---|---|---|
| simvastatin | Active comparator | Not described Receives: Drug: simvastatin |
| Dapagliflozin + simvastatin | Active comparator | Not described Receives: Drug: Dapagliflozin; Drug: simvastatin |
| Dapagliflozin | Active comparator | Not described Receives: Drug: Dapagliflozin |
| valsartan | Active comparator | Not described Receives: Drug: valsartan |
| Dapagliflozin + valsartan | Active comparator | Not described Receives: Drug: Dapagliflozin; Drug: valsartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exposure to the investigational drug will be measured to compare with and without the co-administration of other drugs
Measured: 72 hours post-dose
Secondary outcomes (3)
To assess the safety and tolerability of dapagliflozin when administered alone, with valsartan, or with simvastatin in healthy subjects
Measured: 15 timepoints
To assess the safety and tolerability of the combination of dapagliflozin with valsartan, and the combination of dapagliflozin with simvastatin in healthy subjects
Measured: 15 timepoints
To assess the effect of dapagliflozin on the PK of simvastatin acid (active metabolite of simvastatin), when coadministered in healthy subjects
Measured: 15 timepoints
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionMar 2009
- Study completionMar 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT00839683
- Sponsor's protocol ID
- MB102-036
- Status last verified
- Oct 2016
- First submitted
- 5 Feb 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
- Pharmacokinetic Drug Interaction Study of Dapagliflozin and Valsartan or Simvastatin in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00839683
- Acronym / sponsor ID
- MB102-036
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Study start
- Feb 2009
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 9 Feb 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.
Phase A - To assess the effect of simvastatin on the pharmacokinetics (PK) of dapagliflozin and to determine the effect of dapagliflozin on the PK of simvastatin, when simvastatin and dapagliflozin are coadministered in healthy subjects. Phase B - To assess the effect of valsartan on the PK of dapagliflozin and to determine the effect of dapagliflozin on the PK of valsartan, when valsartan and dapagliflozin are coadministered in healthy subjects
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| simvastatin | Active comparator | Drug: simvastatin |
| Dapagliflozin + simvastatin | Active comparator | Drug: Dapagliflozin, Drug: simvastatin |
| Dapagliflozin | Active comparator | Drug: Dapagliflozin |
| valsartan | Active comparator | Drug: valsartan |
| Dapagliflozin + valsartan | Active comparator | Drug: Dapagliflozin, Drug: valsartan |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
- Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive. BMI = weight (kg)/[height (m)]2
Key exclusion criteria (20 listed)
- Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 12 weeks after the last dose of investigational product
- Abnormal urinalysis at screening (repeat urinalysis may be allowed for positive hematuria in women)
- Glucosuria at screening
- Abnormal liver functions tests (ALT, AST or total bilirubin > 10% above ULN)
- Presence of edema on physical exam
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 |
|---|---|---|
| simvastatinAlso: ZocorTablets, Oral, 20 mg, Single Dose | Drug | simvastatin |
| DapagliflozinAlso: BMS-512148Tablets, Oral, 20 mg, Single Dose | Drug | Dapagliflozin, Dapagliflozin + simvastatin, Dapagliflozin + valsartan |
| simvastatinOral, 40 mg, Single Dose | Drug | Dapagliflozin + simvastatin |
| valsartanAlso: DiovanTablets, Oral, 320 mg, Single Dose | Drug | Dapagliflozin + valsartan, valsartan |
Primary outcome
Exposure to the investigational drug will be measured to compare with and without the co-administration of other drugs
Time frame: 72 hours post-dose
3 secondary outcomes
To assess the safety and tolerability of dapagliflozin when administered alone, with valsartan, or with simvastatin in healthy subjects
Time frame: 15 timepoints
To assess the safety and tolerability of the combination of dapagliflozin with valsartan, and the combination of dapagliflozin with simvastatin in healthy subjects
Time frame: 15 timepoints
To assess the effect of dapagliflozin on the PK of simvastatin acid (active metabolite of simvastatin), when coadministered in healthy subjects
Time frame: 15 timepoints
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.
- MB102-036\_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 simvastatin, Dapagliflozin and valsartan 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 2 inclusion and 20 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?
Exposure to the investigational drug will be measured to compare with and without the co-administration of other drugs (time frame: 72 hours post-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 17 Oct 2016.