HealthyPhase 1NCT01276301

DDI Between BI Empagliflozin (10773) and Verapamil

A Phase 1 study testing Verapamil and BI 10773 in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Relative bioavailability of BI 10773 given alone and together with verapamil Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Verapamil and BI 10773
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteGermany
Study dates: Jan 2011to Feb 2011
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

healthy male and female subjects

Who cannot join

Any relevant deviation from healthy conditions

Trial locations and contacts

1 site in 1 country.

Germany1 site

1245.43.1 Boehringer Ingelheim Investigational Site
Biberach

Other trials in Germany

About this study

Official title: Relative Bioavailability of BI 10773 Given Alone and Together With Verapamil - an Open-label, Randomised, Crossover Trial in Healthy Subjects

Relative bioavailability of BI 10773 given alone and together with verapamil

Conditions: Healthy
Being tested: Verapamil, BI 10773

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VerapamilDrug
single dose verapamil
BI 10773Drug
single dose BI 10773
BI 10773Drug
single dose BI 10773

Study groups in NCT01276301
Study group	Role	What they receive
Reference	Experimental	single dose BI 10773 Receives: Drug: BI 10773
Test	Active comparator	single dose BI 10773 + single dose verapamil Receives: Drug: Verapamil; Drug: BI 10773

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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)
Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to time of last quantifiable data point.
Measured: 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)
Time from last dosing to the maximum plasma concentration
Measured: 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)
Terminal elimination rate constant in plasma.
Note: The numbers provide below for standard deviation are of Coefficient of Variation.
Measured: 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)
Terminal half-life of empagliflozin in plasma.
Note: The numbers provide below for standard deviation are of Coefficient of Variation.
Measured: 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)
Mean residence time of empagliflozin (empa) in the body after oral administration.
Note: The numbers provide below for standard deviation are of Coefficient of Variation.
Measured: 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
Apparent Clearance in Plasma After Extravascular Administration (CL/F)
Apparent clearance of empagliflozin (empa) in plasma after extravascular administration.
Note: The numbers provide below for standard deviation are of Coefficient of Variation.
Measured: 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
Apparent Volume of Distribution Following an Extravascular Dose (Vz/F)
Apparent volume of distribution during the terminal phase following an extravascular dose.
Note: The numbers provide below for standard deviation are of Coefficient of Variation.
Measured: 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
Clinically Relevant Abnormalities for Physical Examination, Vital Signs, Blood Chemistry and Electrocardiogram (ECG).
Clinically relevant abnormalities for physical examination, vital signs , blood chemistry and Electrocardiogram (ECG). New or abnormal findings were reported as adverse events.
Measured: Day1 to Day 11
Assessment of Tolerability by Investigator
Tolerability will be assessed by the investigator according to the categories good, satisfactory, not satisfactory , bad and not assessable.
Measured: Within Day 15 to Day 25

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2011Feb 2011

First posted13 Jan 2011 (estimated)
Study startJan 2011
Primary completionFeb 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01276301
Sponsor's protocol ID: 1245.43
Other IDs: 2010-023059-27
Status last verified: May 2014
First submitted: 12 Jan 2011
Last updated: 17 Jun 2014
Results posted: Yes, on ClinicalTrials.gov

Publications

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.
PubMed 23497760

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 17 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Relative Bioavailability of BI 10773 Given Alone and Together With Verapamil - an Open-label, Randomised, Crossover Trial in Healthy Subjects
ClinicalTrials.gov ID: NCT01276301
Acronym / sponsor ID: 1245.43
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Jan 2011
Primary completion: Feb 2011 (actual)
First posted: 13 Jan 2011 (estimated)
Results: Posted 17 Jun 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Relative bioavailability of BI 10773 given alone and together with verapamil

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Reference	Experimental	Drug: BI 10773single dose BI 10773
Test	Active comparator	Drug: Verapamil, Drug: BI 10773single dose BI 10773 + single dose verapamil

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

healthy male and female subjects

Key exclusion criteria (1 listed)

Any relevant deviation from healthy conditions

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Verapamilsingle dose verapamil	Drug	Test
BI 10773single dose BI 10773	Drug	Reference
BI 10773single dose BI 10773	Drug	Test

Primary outcome

Area Under the Curve 0 to Infinity (AUC0-∞)
Time frame: 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
Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 extrapolated to infinity.
Maximum Measured Concentration (Cmax)
Time frame: 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 of empagliflozin (empa) in plasma.

9 secondary outcomes

Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Apparent Clearance in Plasma After Extravascular Administration (CL/F)
Time frame: 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
Apparent Volume of Distribution Following an Extravascular Dose (Vz/F)
Time frame: 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
Clinically Relevant Abnormalities for Physical Examination, Vital Signs, Blood Chemistry and Electrocardiogram (ECG).
Time frame: Day1 to Day 11
Assessment of Tolerability by Investigator
Time frame: Within Day 15 to Day 25

Results and safety

Results posted to the registry on 17 Jun 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Empa / Empa Plus Verapamil	8	8
Empa Plus Verapamil / Empa	8	8

Primary outcome: Area Under the Curve 0 to Infinity (AUC0-∞)

Time frame: 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. Geometric mean (Geometric Coefficient of Variation). Unit: nmol*h/L

Measure	Empa n = 16	Empa Plus Verapamil n = 16
Value	5190 (25.0)	5340 (25.5)

Empa vs Empa Plus Verapamil: Geometric Mean Ratio: 102.95 (90% CI 98.87 to 107.02), ANOVA

Population analysed: Pharmacokinetic (PK) set: All subjects who had taken at least one dose of trial medication, who had provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.

Primary outcome: Maximum Measured Concentration (Cmax)

Measure	Empa n = 16	Empa Plus Verapamil n = 16
Value	785 (31.5)	725 (29.1)

Empa vs Empa Plus Verapamil: Geometric Mean Ratio: 92.39 (90% CI 85.38 to 99.97), ANOVA

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day1 to Day 11. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Empa	0 of 16 (0%)	8 of 16 (50%)	Not reported
Empa Plus Verapamil	0 of 16 (0%)	9 of 16 (56.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23497760Macha 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.
Related InfoLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Verapamil and BI 10773 in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Curve 0 to Infinity (AUC0-∞) (time frame: 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01276301, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2014.