NCT01304329

Brief Summary

The objective of the study is to investigate the drug-drug interaction potential between BI 10773 and simvastatin.

Trial Health

80
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

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

February 1, 2011

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

February 21, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 25, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

July 28, 2014

Completed
Last Updated

July 28, 2014

Status Verified

July 1, 2014

Enrollment Period

2 months

First QC Date

February 21, 2011

Results QC Date

May 16, 2014

Last Update Submit

July 2, 2014

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

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

    Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity. The geometric mean (gMean) and geometric coefficient of variation (gCV) are adjusted values.

    0 hours (h), 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration

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

    Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity. Simvastatin acid is an active metabolite of simvastatin. The geometric mean (gMean) and geometric coefficient of variation (gCV) are adjusted values.

    0 hours (h), 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration

  • Empa: Maximum Measured Concentration (Cmax)

    Maximum measured concentration of the analyte in plasma, per period. The geometric mean and geometric coefficient of variation (gCV) are adjusted values

    0 hours (h), 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration

  • Simvastatin: Maximum Measured Concentration (Cmax)

    Maximum measured concentration of the analyte in plasma, per period. The geometric mean and geometric coefficient of variation (gCV) are adjusted values.

    0 hours (h), 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration

Secondary Outcomes (2)

  • Empa: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)

    0 hours (h), 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration

  • Simvastatin: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)

    0 hours (h), 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration

Study Arms (3)

treatment A, reference

EXPERIMENTAL

1 tablet BI 10773, oral administration with 240 ml water

Drug: BI 10773

treatment B, reference

EXPERIMENTAL

1 tablet simvastatin, oral administration with 240 ml water

Drug: simvastatin

treatment C, test

EXPERIMENTAL

1 tablet BI 10773 + 1 tablet simvastatin, oral administration with 240 ml water

Drug: BI 10773Drug: simvastatin

Interventions

BI 10773DRUG

Medium dose oral administration

treatment C, test
simvastatinDRUG

Medium dose oral administration

treatment C, test

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)

1245.63.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

Location

MeSH Terms

Interventions

empagliflozinSimvastatin

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic 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
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

February 21, 2011

First Posted

February 25, 2011

Study Start

February 1, 2011

Primary Completion

April 1, 2011

Last Updated

July 28, 2014

Results First Posted

July 28, 2014

Record last verified: 2014-07

Locations

DE(1)