Effect of Rifampin on the Pharmacokinetics of Dapagliflozin in Healthy Subjects

NCT ID: NCT01068756

Last Updated: 2016-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-04-30

Brief Summary

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

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Dapagliflozin/Rifampin

Group Type OTHER

Dapagliflozin

Intervention Type DRUG

Tablets, Oral, 10 mg, 2 single oral 10 mg doses, 2 days

Rifampin

Intervention Type DRUG

Capsules, Oral, 600 mg, Once daily on days 4 to 11, 8 days

Interventions

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Dapagliflozin

Tablets, Oral, 10 mg, 2 single oral 10 mg doses, 2 days

Intervention Type DRUG

Rifampin

Capsules, Oral, 600 mg, Once daily on days 4 to 11, 8 days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Ppd Development

Austin, Texas, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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MB102-074

Identifier Type: -

Identifier Source: org_study_id

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