NCT01068756

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_1 type-2-diabetes-mellitus

Timeline
Completed

Started Mar 2010

Shorter than P25 for phase_1 type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 15, 2010

Completed
14 days until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

October 17, 2016

Status Verified

October 1, 2016

Enrollment Period

1 month

First QC Date

February 12, 2010

Last Update Submit

October 14, 2016

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • 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

  • 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

Study Arms (1)

Dapagliflozin/Rifampin

OTHER
Drug: DapagliflozinDrug: Rifampin

Interventions

DapagliflozinDRUG

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

Dapagliflozin/Rifampin
RifampinDRUG

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

Dapagliflozin/Rifampin

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ppd Development

Austin, Texas, 78744, United States

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dapagliflozinRifampin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

RifamycinsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsLactams, MacrocyclicMacrocyclic CompoundsPolycyclic Compounds

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2010

First Posted

February 15, 2010

Study Start

March 1, 2010

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

October 17, 2016

Record last verified: 2016-10

Locations

US(1)