Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of Ultra Low Doses of Dapagliflozin in Healthy Subjects
ULDS
1 other identifier
interventional
35
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 type-2-diabetes
Started May 2010
Shorter than P25 for phase_1 type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 27, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedFirst Posted
Study publicly available on registry
June 2, 2010
CompletedOctober 17, 2016
October 1, 2016
1 month
May 27, 2010
October 14, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Total 24-hour Urinary Glucose Excretion as a Measure of Pharmacodynamic Effect
24 hours after dosing
Secondary Outcomes (2)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
24 hours after dosing
Dapagliflozin and Dapagliflozin 3-O-glucuronide (Metabolite of Dapagliflozin) Concentrations to Characterize Dapagliflozin Pharmacokinetics
2 days after dosing
Study Arms (6)
dapagliflozin (0.001 mg)
EXPERIMENTALCohort 1
dapagliflozin (0.01 mg)
EXPERIMENTALCohort 2
dapagliflozin (0.1 mg)
EXPERIMENTALCohort 3
dapagliflozin (0.3 mg)
EXPERIMENTALCohort 4
dapagliflozin (1 mg)
EXPERIMENTALCohort 5
dapagliflozin (2.5 mg)
EXPERIMENTALCohort 6
Interventions
Oral Solution, Oral, 0.001 mg, once on Day 1 only, 2 days
Eligibility Criteria
You may qualify if:
- Healthy men and women
- WOCBP who are using acceptable method of contraception
- Women who are not nursing
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Bristol-Myers Squibbcollaborator
Study Sites (1)
Ppd Development, Lp
Austin, Texas, 78744, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2010
First Posted
June 2, 2010
Study Start
May 1, 2010
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
October 17, 2016
Record last verified: 2016-10