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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:
Collaborator:
AstraZeneca
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01135446
First received: May 27, 2010
Last updated: February 22, 2011
Last verified: January 2011
History of Changes

May 27, 2010
February 22, 2011
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
  • Dapagliflozin and Dapagliflozin 3-O-glucuronide (Metabolite of Dapagliflozin) Concentrations to Characterize Dapagliflozin Pharmacokinetics [ Time Frame: 2 days after dosing ] [ Designated as safety issue: No ]
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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Diabetes Mellitus, Non-Insulin-Dependent
  • 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
0
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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01135446
MB102-088
No
Study Director, Bristol-Myers Squibb
Bristol-Myers Squibb
AstraZeneca
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
January 2011

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