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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
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Non-Insulin-Dependent
 Drug: dapagliflozin
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of Ultra Low Doses of Dapagliflozin in Healthy Subjects

Resource links provided by NLM:

MedlinePlus related topics: Diabetes
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Total 24-hour Urinary Glucose Excretion as a Measure of Pharmacodynamic Effect [ Time Frame: 24 hours after dosing ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 0
Study Start Date: May 2010
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: dapagliflozin (0.001 mg)
Cohort 1
 Drug: dapagliflozin
Oral Solution, Oral, 0.001 mg, once on Day 1 only, 2 days
Other Name: BMS-512148
Experimental: dapagliflozin (0.01 mg)
Cohort 2
 Drug: dapagliflozin
Oral Solution, Oral, 0.01 mg, once on Day 1 only, 2 days
Other Name: BMS-512148
Experimental: dapagliflozin (0.1 mg)
Cohort 3
 Drug: dapagliflozin
Oral Solution, Oral, 0.1 mg, once on Day 1 only, 2 days
Other Name: BMS-512148
Experimental: dapagliflozin (0.3 mg)
Cohort 4
 Drug: dapagliflozin
Tablets, Oral, 0.3 mg, once on Day 1 only, 2 days
Other Name: BMS-512148
Experimental: dapagliflozin (1 mg)
Cohort 5
 Drug: dapagliflozin
Tablets, Oral, 1 mg, once on Day 1 only, 2 days
Other Name: BMS-512148
Experimental: dapagliflozin (2.5 mg)
Cohort 6
 Drug: dapagliflozin
Tablets, Oral, 2.5 mg, once on Day 1 only, 2 days
Other Name: BMS-512148

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01135446

Locations
United States, Texas
Ppd Development, Lp
Austin, Texas, United States, 78744
Sponsors and Collaborators
Bristol-Myers Squibb
AstraZeneca
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01135446     History of Changes
Other Study ID Numbers: MB102-088
Study First Received: May 27, 2010
Last Updated: February 22, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 18, 2013