Effect of Rifampin on the Pharmacokinetics of Dapagliflozin in Healthy Subjects

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Effect of Rifampin on the Pharmacokinetics of Dapagliflozin in Healthy Subjects

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01068756
• Other study ID #: MB102-074
• Status: Terminated
• Phase: Phase 1
• First received: February 12, 2010
• Last updated: October 14, 2016
• Start date: March 2010
• Est. completion date: April 2010

Study information

• Verified date: October 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Dapagliflozin
Tablets, Oral, 10 mg, 2 single oral 10 mg doses, 2 days
• Rifampin
Capsules, Oral, 600 mg, Once daily on days 4 to 11, 8 days

Locations

Country	Name	City	State
United States	Ppd Development	Austin	Texas

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC (area under the concentration-time curve) Single dose pharmacokinetic parameter will be derived from plasma concentration versus time data		Days 1 to 3 and Days 9 to 11	No
Secondary	Cmax (maximum observed concentration) Single dose pharmacokinetic parameter will be derived from plasma concentration versus time data		Days 1 to 3 and Days 9 to 11	No
Secondary	Tmax (time of maximum observed concentration) Single dose pharmacokinetic parameter will be derived from plasma concentration versus time data		Days 1 to 3 and Days 9 to 11	No

External Links

•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   MB102-074_redacted_CSR_synopsis