NCT01301742

Brief Summary

To investigate the relative bioavailability of BI 10773 following coadministration with 600 mg gemfibrozil bid dosed to steady-state in comparison to BI 10773 when given alone.

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
21 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 23, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

June 18, 2014

Completed
Last Updated

June 18, 2014

Status Verified

May 1, 2014

Enrollment Period

3 months

First QC Date

February 22, 2011

Results QC Date

May 16, 2014

Last Update Submit

May 16, 2014

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

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

    Area under the plasma concentration-time curve of the analyte from time 0 extrapolated to infinity. The standard deviation presented in the analysis is actually the intra-individual geometric standard deviation (gCV).

    0 minutes (min), 20 min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 23h, 36h, 47h, 71h after the first dose

  • Total Empa: Maximum Measured Concentration (Cmax)

    Maximum measured concentration of total Empagliflozin (Empa) in plasma, per period. The standard deviation presented in the analysis is actually the intra-individual geometric standard deviation (gCV).

    0 minutes (min), 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 23h, 36h, 47h, 71h after the first dose

Secondary Outcomes (1)

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

    0 minutes (min), 20 min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 23h, 36h, 47h, 71h after the first dose

Study Arms (2)

BI 10773

ACTIVE COMPARATOR

Subject to receive one single dose BI 10773

Drug: BI 10773Drug: Gemfibrozil

BI 10773 plus gemfibrozil

EXPERIMENTAL

Subject to receive one single dose BI 10773 plus 600 mg gemfibrozil bid for 5 days

Drug: BI 10773

Interventions

BI 10773DRUG

1 tablet single dose BI 10773 in the morning

BI 10773
GemfibrozilDRUG

Gemfibrozil 600 mg bid for 5 days

BI 10773

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- Healthy male and female subjects

You may not qualify if:

  • \- Any finding of the medical examination (including Blood Pressure, Pulse Rate and Electrocardiogram) deviating from normal and of clinical relevance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1245.58.1 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

empagliflozinGemfibrozil

Intervention Hierarchy (Ancestors)

Fibric AcidsIsobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPentanoic AcidsValeratesPhenyl EthersEthersPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsFatty Acids, VolatileFatty AcidsLipids

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 22, 2011

First Posted

February 23, 2011

Study Start

February 1, 2011

Primary Completion

May 1, 2011

Last Updated

June 18, 2014

Results First Posted

June 18, 2014

Record last verified: 2014-05

Locations

DE(1)