Type 2 DiabetesPhase 1ULDSNCT01135446
Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of Ultra Low Doses of Dapagliflozin in Healthy Subjects
A Phase 1 study testing dapagliflozin in people with Type 2 Diabetes, run by AstraZeneca at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the pharmacodynamics (PD), pharmacokinetics (PK), safety and tolerability following single oral doses of 0.001 mg to 2.5 mg dapagliflozin in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- dapagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Jun 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women
- WOCBP who are using acceptable method of contraception
- Women who are not nursing
Who cannot join
- History of GI disease
- Any GI surgery that could impact study drug absorption
- Glucosuria at screening or Day -2
- Abnormal liver function tests (ALT, AST or total bilirubin > 10% above ULN)
- History of current or recurrent UTI
- History of Diabetes Mellitus
Show all 9Show fewer
- History of chronic or recurrent vulvovaginal mycotic infections
- Estimated creatinine clearance (ClCr) < 80 mL/min using Cockroft-Gault formula
- History of allergy to SGLT2 inhibitors or related compounds
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the pharmacodynamics (PD), pharmacokinetics (PK), safety and tolerability following single oral doses of 0.001 mg to 2.5 mg dapagliflozin in healthy subjects.
- Conditions
- Type 2 Diabetes
- 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
Also called BMS-512148
Oral Solution, Oral, 0.001 mg, once on Day 1 only, 2 days
dapagliflozinDrug
Also called BMS-512148
Oral Solution, Oral, 0.01 mg, once on Day 1 only, 2 days
dapagliflozinDrug
Also called BMS-512148
Oral Solution, Oral, 0.1 mg, once on Day 1 only, 2 days
dapagliflozinDrug
Also called BMS-512148
Tablets, Oral, 0.3 mg, once on Day 1 only, 2 days
dapagliflozinDrug
Also called BMS-512148
Tablets, Oral, 1 mg, once on Day 1 only, 2 days
dapagliflozinDrug
Also called BMS-512148
Tablets, Oral, 2.5 mg, once on Day 1 only, 2 days
| Study group | Role | What they receive |
|---|---|---|
| dapagliflozin (0.001 mg) | Experimental | Cohort 1 Receives: Drug: dapagliflozin |
| dapagliflozin (0.01 mg) | Experimental | Cohort 2 Receives: Drug: dapagliflozin |
| dapagliflozin (0.1 mg) | Experimental | Cohort 3 Receives: Drug: dapagliflozin |
| dapagliflozin (0.3 mg) | Experimental | Cohort 4 Receives: Drug: dapagliflozin |
| dapagliflozin (1 mg) | Experimental | Cohort 5 Receives: Drug: dapagliflozin |
| dapagliflozin (2.5 mg) | Experimental | Cohort 6 Receives: Drug: dapagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total 24-hour Urinary Glucose Excretion as a Measure of Pharmacodynamic Effect
Measured: 24 hours after dosing
Secondary outcomes (2)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: 24 hours after dosing
Dapagliflozin and Dapagliflozin 3-O-glucuronide (Metabolite of Dapagliflozin) Concentrations to Characterize Dapagliflozin Pharmacokinetics
Measured: 2 days after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2010 (estimated)
- Study startMay 2010
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 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
- NCT01135446
- Sponsor's protocol ID
- MB102-088
- Acronym
- ULDS
- Status last verified
- Oct 2016
- First submitted
- 27 May 2010
- 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
- Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of Ultra Low Doses of Dapagliflozin in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01135446
- Acronym / sponsor ID
- ULDS / MB102-088
- Conditions
- Type 2 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Study start
- May 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 2 Jun 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.
The purpose of this study is to evaluate the pharmacodynamics (PD), pharmacokinetics (PK), safety and tolerability following single oral doses of 0.001 mg to 2.5 mg dapagliflozin in healthy subjects.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| dapagliflozin (0.001 mg) | Experimental | Drug: dapagliflozinCohort 1 |
| dapagliflozin (0.01 mg) | Experimental | Drug: dapagliflozinCohort 2 |
| dapagliflozin (0.1 mg) | Experimental | Drug: dapagliflozinCohort 3 |
| dapagliflozin (0.3 mg) | Experimental | Drug: dapagliflozinCohort 4 |
| dapagliflozin (1 mg) | Experimental | Drug: dapagliflozinCohort 5 |
| dapagliflozin (2.5 mg) | Experimental | Drug: dapagliflozinCohort 6 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy men and women
- WOCBP who are using acceptable method of contraception
- Women who are not nursing
Key exclusion criteria (9 listed)
- History of GI disease
- Any GI surgery that could impact study drug absorption
- Glucosuria at screening or Day -2
- Abnormal liver function tests (ALT, AST or total bilirubin > 10% above ULN)
- History of current or recurrent UTI
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 |
|---|---|---|
| dapagliflozinAlso: BMS-512148Oral Solution, Oral, 0.001 mg, once on Day 1 only, 2 days | Drug | dapagliflozin (0.001 mg) |
| dapagliflozinAlso: BMS-512148Oral Solution, Oral, 0.01 mg, once on Day 1 only, 2 days | Drug | dapagliflozin (0.01 mg) |
| dapagliflozinAlso: BMS-512148Oral Solution, Oral, 0.1 mg, once on Day 1 only, 2 days | Drug | dapagliflozin (0.1 mg) |
| dapagliflozinAlso: BMS-512148Tablets, Oral, 0.3 mg, once on Day 1 only, 2 days | Drug | dapagliflozin (0.3 mg) |
| dapagliflozinAlso: BMS-512148Tablets, Oral, 1 mg, once on Day 1 only, 2 days | Drug | dapagliflozin (1 mg) |
| dapagliflozinAlso: BMS-512148Tablets, Oral, 2.5 mg, once on Day 1 only, 2 days | Drug | dapagliflozin (2.5 mg) |
Primary outcome
Total 24-hour Urinary Glucose Excretion as a Measure of Pharmacodynamic Effect
Time frame: 24 hours after dosing
2 secondary outcomes
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 24 hours after dosing
Dapagliflozin and Dapagliflozin 3-O-glucuronide (Metabolite of Dapagliflozin) Concentrations to Characterize Dapagliflozin Pharmacokinetics
Time frame: 2 days after dosing
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.
- MB102-088\_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, 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 9 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?
Total 24-hour Urinary Glucose Excretion as a Measure of Pharmacodynamic Effect (time frame: 24 hours after dosing). 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.