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

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ClinicalTrials.gov Identifier: NCT01135446
Recruitment Status : Completed
First Posted : June 2, 2010
Last Update Posted : October 17, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: dapagliflozin Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of Ultra Low Doses of Dapagliflozin in Healthy Subjects
Study Start Date : May 2010
Primary Completion Date : June 2010
Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Total 24-hour Urinary Glucose Excretion as a Measure of Pharmacodynamic Effect [ Time Frame: 24 hours after dosing ]

Secondary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 24 hours after dosing ]
  2. Dapagliflozin and Dapagliflozin 3-O-glucuronide (Metabolite of Dapagliflozin) Concentrations to Characterize Dapagliflozin Pharmacokinetics [ Time Frame: 2 days after dosing ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01135446


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

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01135446     History of Changes
Other Study ID Numbers: MB102-088
First Posted: June 2, 2010    Key Record Dates
Last Update Posted: October 17, 2016
Last Verified: October 2016