NCT01276301

Brief Summary

Relative bioavailability of BI 10773 given alone and together with verapamil

Trial Health

80
On Track

Trial Health Score

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

Enrollment
16

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

January 1, 2011

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 12, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2011

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

June 17, 2014

Completed
Last Updated

June 17, 2014

Status Verified

May 1, 2014

Enrollment Period

1 month

First QC Date

January 12, 2011

Results QC Date

May 16, 2014

Last Update Submit

May 16, 2014

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

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

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

    0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration

  • Maximum Measured Concentration (Cmax)

    Maximum measured concentration of empagliflozin (empa) in plasma.

    0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration

Secondary Outcomes (9)

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

    0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration

  • Time From 0 to Maximum Plasma Concentration (Tmax)

    0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration

  • Terminal Elimination Rate Constant (λz)

    0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration

  • Terminal Half-life in Plasma (t1/2)

    0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration

  • Mean Residence Time in the Body After Administration (MRTpo)

    0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration

  • +4 more secondary outcomes

Other Outcomes (1)

  • Verapamil Plasma Concentration

    Predose and 1 hour (h), 25h, 49h and 73h after verapamil administration

Study Arms (2)

Reference

EXPERIMENTAL

single dose BI 10773

Drug: BI 10773

Test

ACTIVE COMPARATOR

single dose BI 10773 + single dose verapamil

Drug: VerapamilDrug: BI 10773

Interventions

VerapamilDRUG

single dose verapamil

Test
BI 10773DRUG

single dose BI 10773

Reference

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)

1245.43.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

Location

Related Publications (1)

  • Macha S, Sennewald R, Rose P, Schoene K, Pinnetti S, Woerle HJ, Broedl UC. Lack of clinically relevant drug-drug interaction between empagliflozin, a sodium glucose cotransporter 2 inhibitor, and verapamil, ramipril, or digoxin in healthy volunteers. Clin Ther. 2013 Mar;35(3):226-35. doi: 10.1016/j.clinthera.2013.02.015.

    PMID: 23497760DERIVED

MeSH Terms

Interventions

Verapamilempagliflozin

Intervention Hierarchy (Ancestors)

PhenethylaminesEthylaminesAminesOrganic Chemicals

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

January 12, 2011

First Posted

January 13, 2011

Study Start

January 1, 2011

Primary Completion

February 1, 2011

Last Updated

June 17, 2014

Results First Posted

June 17, 2014

Record last verified: 2014-05

Locations

DE(1)