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Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of Ultra Low Doses of Dapagliflozin in Healthy Subjects (ULDS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01135446
First Posted: June 2, 2010
Last Update Posted: October 17, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
May 27, 2010
June 2, 2010
October 17, 2016
May 2010
June 2010   (Final data collection date for primary outcome measure)
Total 24-hour Urinary Glucose Excretion as a Measure of Pharmacodynamic Effect [ Time Frame: 24 hours after dosing ]
Same as current
Complete list of historical versions of study NCT01135446 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of Ultra Low Doses of Dapagliflozin in Healthy Subjects
Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of Ultra Low Doses of Dapagliflozin in Healthy Subjects
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Type 2 Diabetes
  • Drug: dapagliflozin
    Oral Solution, Oral, 0.001 mg, once on Day 1 only, 2 days
    Other Name: BMS-512148
  • Drug: dapagliflozin
    Oral Solution, Oral, 0.01 mg, once on Day 1 only, 2 days
    Other Name: BMS-512148
  • Drug: dapagliflozin
    Oral Solution, Oral, 0.1 mg, once on Day 1 only, 2 days
    Other Name: BMS-512148
  • Drug: dapagliflozin
    Tablets, Oral, 0.3 mg, once on Day 1 only, 2 days
    Other Name: BMS-512148
  • Drug: dapagliflozin
    Tablets, Oral, 1 mg, once on Day 1 only, 2 days
    Other Name: BMS-512148
  • Drug: dapagliflozin
    Tablets, Oral, 2.5 mg, once on Day 1 only, 2 days
    Other Name: BMS-512148
  • Experimental: dapagliflozin (0.001 mg)
    Cohort 1
    Intervention: Drug: dapagliflozin
  • Experimental: dapagliflozin (0.01 mg)
    Cohort 2
    Intervention: Drug: dapagliflozin
  • Experimental: dapagliflozin (0.1 mg)
    Cohort 3
    Intervention: Drug: dapagliflozin
  • Experimental: dapagliflozin (0.3 mg)
    Cohort 4
    Intervention: Drug: dapagliflozin
  • Experimental: dapagliflozin (1 mg)
    Cohort 5
    Intervention: Drug: dapagliflozin
  • Experimental: dapagliflozin (2.5 mg)
    Cohort 6
    Intervention: Drug: dapagliflozin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
June 2010
June 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy men and women
  • WOCBP who are using acceptable method of contraception
  • Women who are not nursing

Exclusion Criteria:

  • 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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01135446
MB102-088
No
Not Provided
Not Provided
AstraZeneca
AstraZeneca
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
AstraZeneca
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP