Effect of Rifampin on the Pharmacokinetics of Dapagliflozin in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01068756
First received: February 12, 2010
Last updated: June 9, 2014
Last verified: June 2014
  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:


Further study details as provided by AstraZeneca:

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: 14
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
AstraZeneca
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01068756     History of Changes
Other Study ID Numbers: MB102-074
Study First Received: February 12, 2010
Last Updated: June 9, 2014
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 August 19, 2014