Effect of Rifampin on the Pharmacokinetics of Dapagliflozin in Healthy Subjects

AstraZeneca

Status and phase: Terminated; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Rifampin; Drug: Dapagliflozin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01068756

MB102-074

Details and patient eligibility

About

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

Enrollment: 14 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

14 participants in 1 patient group

Dapagliflozin/Rifampin

Other group

Treatment:

Drug: Rifampin

Drug: Dapagliflozin