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Effect of Rifampin on the Pharmacokinetics of Dapagliflozin in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01068756
First received: February 12, 2010
Last updated: February 22, 2011
Last verified: January 2011
History of Changes
  Purpose

The purpose of the study is to assess the effects of rifampin on the pharmacokinetics of dapagliflozin


Condition Intervention Phase
Type 2 Diabetes Mellitus
 Drug: Dapagliflozin
Drug: Rifampin
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Effect of Rifampin on the Pharmacokinetics of Dapagliflozin in Healthy Subjects

Resource links provided by NLM:

Drug Information available for: Rifampin
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • AUC (area under the concentration-time curve) Single dose pharmacokinetic parameter will be derived from plasma concentration versus time data [ Time Frame: Days 1 to 3 and Days 9 to 11 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cmax (maximum observed concentration) Single dose pharmacokinetic parameter will be derived from plasma concentration versus time data [ Time Frame: Days 1 to 3 and Days 9 to 11 ] [ Designated as safety issue: No ]
  • Tmax (time of maximum observed concentration) Single dose pharmacokinetic parameter will be derived from plasma concentration versus time data [ Time Frame: Days 1 to 3 and Days 9 to 11 ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: March 2010
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Dapagliflozin/Rifampin Drug: Dapagliflozin
Tablets, Oral, 10 mg, 2 single oral 10 mg doses, 2 days
Drug: Rifampin
Capsules, Oral, 600 mg, Once daily on days 4 to 11, 8 days

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subjects
  • Body Mass Index (BMI) of 18 to 32 inclusive
  • Women who are not of childbearing potential and men, ages 18 to 45

Exclusion Criteria:

  • Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, electrocardiogram (ECG) or clinical laboratory determinations
  • Glucosuria
  • Abnormal liver function tests
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01068756

Locations
United States, Texas
Ppd Development
Austin, Texas, United States, 78744
Sponsors and Collaborators
Bristol-Myers Squibb
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: NCT01068756     History of Changes
Other Study ID Numbers: MB102-074
Study First Received: February 12, 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
Rifampin
Antibiotics, Antitubercular
Anti-Bacterial Agents
 Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on May 21, 2013