Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of Ultra Low Doses of Dapagliflozin in Healthy Subjects
NCT ID: NCT01135446
Last Updated: 2016-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
35 participants
INTERVENTIONAL
2010-05-31
2010-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
NONE
Study Groups
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dapagliflozin (0.001 mg)
Cohort 1
dapagliflozin
Oral Solution, Oral, 0.001 mg, once on Day 1 only, 2 days
dapagliflozin (0.01 mg)
Cohort 2
dapagliflozin
Oral Solution, Oral, 0.01 mg, once on Day 1 only, 2 days
dapagliflozin (0.1 mg)
Cohort 3
dapagliflozin
Oral Solution, Oral, 0.1 mg, once on Day 1 only, 2 days
dapagliflozin (0.3 mg)
Cohort 4
dapagliflozin
Tablets, Oral, 0.3 mg, once on Day 1 only, 2 days
dapagliflozin (1 mg)
Cohort 5
dapagliflozin
Tablets, Oral, 1 mg, once on Day 1 only, 2 days
dapagliflozin (2.5 mg)
Cohort 6
dapagliflozin
Tablets, Oral, 2.5 mg, once on Day 1 only, 2 days
Interventions
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dapagliflozin
Oral Solution, Oral, 0.001 mg, once on Day 1 only, 2 days
dapagliflozin
Oral Solution, Oral, 0.01 mg, once on Day 1 only, 2 days
dapagliflozin
Oral Solution, Oral, 0.1 mg, once on Day 1 only, 2 days
dapagliflozin
Tablets, Oral, 0.3 mg, once on Day 1 only, 2 days
dapagliflozin
Tablets, Oral, 1 mg, once on Day 1 only, 2 days
dapagliflozin
Tablets, Oral, 2.5 mg, once on Day 1 only, 2 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* WOCBP who are using acceptable method of contraception
* Women who are not nursing
Exclusion Criteria
* 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
* 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
18 Years
55 Years
ALL
Yes
Sponsors
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Bristol-Myers Squibb
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Ppd Development, Lp
Austin, Texas, United States
Countries
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Related Links
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MB102-088\_redacted\_CSR\_synopsis
Other Identifiers
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MB102-088
Identifier Type: -
Identifier Source: org_study_id
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