NCT01634100

Brief Summary

The objectives of the trial are to investigate the effect of concurrent administration of rifampicin and probenecid on the pharmacokinetics of empagliflozin.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Jun 2012

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 3, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 6, 2012

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

July 3, 2014

Completed
Last Updated

July 3, 2014

Status Verified

June 1, 2014

Enrollment Period

2 months

First QC Date

July 3, 2012

Results QC Date

May 16, 2014

Last Update Submit

June 27, 2014

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Total Empagliflozin: Area Under the Curve 0 to Infinity (AUC0-∞)

    Area under the concentration-time curve of total empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity.

    15 minutes (min) prior to the first dose and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h and 72h after the first dose

  • Total Empa: Maximum Measured Concentration (Cmax)

    Maximum measured concentration of total empa in plasma, per period.

    15 minutes (min) prior to the first dose and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h and 72h after the first dose

Secondary Outcomes (1)

  • Total Empagliflozin: Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz)

    15 minutes (min) prior to the first dose and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h and 72h after the first dose

Study Arms (3)

A (Reference)

EXPERIMENTAL

Empagliflozin (BI 10773), Film-coated tablet, single dose

Drug: ProbenecidDrug: EmpagliflozinDrug: Rifampicin

B (Test 1)

EXPERIMENTAL

Empagliflozin (BI 10773), Film-coated tablet, single dose, and Rifampicin,Film-coated tablet single dose

Drug: RifampicinDrug: Empagliflozin

C (Test 2)

EXPERIMENTAL

Empagliflozin (BI 10773), Film-coated tablet, single dose, and Probenecid Tablet twice daily

Drug: ProbenecidDrug: Empagliflozin (BI 10773)

Interventions

ProbenecidDRUG

Probenecid

A (Reference)
RifampicinDRUG

Rifampicin

B (Test 1)
EmpagliflozinDRUG

BI Drug

A (Reference)
Empagliflozin (BI 10773)DRUG

BI Drug

C (Test 2)

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \. healthy male and female subjects

You may not qualify if:

  • \. any relevant deviation from healthy conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1245.83.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

Location

Related Publications (1)

  • Macha S, Koenen R, Sennewald R, Schone K, Hummel N, Riedmaier S, Woerle HJ, Salsali A, Broedl UC. Effect of gemfibrozil, rifampicin, or probenecid on the pharmacokinetics of the SGLT2 inhibitor empagliflozin in healthy volunteers. Clin Ther. 2014 Feb 1;36(2):280-90.e1. doi: 10.1016/j.clinthera.2014.01.003. Epub 2014 Feb 1.

    PMID: 24491572DERIVED

MeSH Terms

Interventions

ProbenecidRifampinempagliflozin

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsRifamycinsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsLactams, MacrocyclicMacrocyclic CompoundsPolycyclic Compounds

Results Point of Contact

Title
Boehringer Ingelheim Call center
Organization
Boehringer Ingelheim Pharmaceuticals
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2012

First Posted

July 6, 2012

Study Start

June 1, 2012

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

July 3, 2014

Results First Posted

July 3, 2014

Record last verified: 2014-06

Locations

DE(1)