HealthyPhase 1NCT01304329

Drug-drug Interaction of Empagliflozin (BI 10773) and Simvastatin

A Phase 1 study testing BI 10773 and simvastatin 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

The objective of the study is to investigate the drug-drug interaction potential between BI 10773 and simvastatin. 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?: BI 10773 and simvastatin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteGermany
Study dates: Feb 2011to Apr 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

1245.63.1 Boehringer Ingelheim Investigational Site
Biberach

Other trials in Germany

About this study

Official title: Relative Bioavailability of BI 10773 and Simvastatin After Single and Combined Administration - an Open-label, Randomised, Crossover Trial in Healthy Subjects

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

Conditions: Healthy
Being tested: BI 10773, simvastatin

What participants receive

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

BI 10773Drug
Medium dose oral administration
simvastatinDrug
Medium dose oral administration
simvastatinDrug
Medium dose oral administration
BI 10773Drug
Medium dose oral administration

Study groups in NCT01304329
Study group	Role	What they receive
treatment A, reference	Experimental	1 tablet BI 10773, oral administration with 240 ml water Receives: Drug: BI 10773
treatment B, reference	Experimental	1 tablet simvastatin, oral administration with 240 ml water Receives: Drug: simvastatin
treatment C, test	Experimental	1 tablet BI 10773 + 1 tablet simvastatin, oral administration with 240 ml water Receives: Drug: BI 10773; Drug: simvastatin

What is being measured

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

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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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)
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point.
The geometric mean and geometric coefficient of variation (gCV) are adjusted values.
Measured: 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)
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point.
The geometric mean and geometric coefficient of variation (gCV) are adjusted values.
Measured: 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

Timeline

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

Feb 2011Apr 2011

First posted25 Feb 2011 (estimated)
Study startFeb 2011
Primary completionApr 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.
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: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01304329
Sponsor's protocol ID: 1245.63
Other IDs: 2010-023680-18
Status last verified: Jul 2014
First submitted: 21 Feb 2011
Last updated: 28 Jul 2014
Results posted: Yes, on ClinicalTrials.gov

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?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Relative Bioavailability of BI 10773 and Simvastatin After Single and Combined Administration - an Open-label, Randomised, Crossover Trial in Healthy Subjects
ClinicalTrials.gov ID: NCT01304329
Acronym / sponsor ID: 1245.63
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Feb 2011
Primary completion: Apr 2011 (actual)
First posted: 25 Feb 2011 (estimated)
Results: Posted 28 Jul 2014

Clinical summary

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

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
treatment A, reference	Experimental	Drug: BI 107731 tablet BI 10773, oral administration with 240 ml water
treatment B, reference	Experimental	Drug: simvastatin1 tablet simvastatin, oral administration with 240 ml water
treatment C, test	Experimental	Drug: BI 10773, Drug: simvastatin1 tablet BI 10773 + 1 tablet simvastatin, oral administration with 240 ml water

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
BI 10773Medium dose oral administration	Drug	treatment C, test
simvastatinMedium dose oral administration	Drug	treatment C, test
simvastatinMedium dose oral administration	Drug	treatment B, reference
BI 10773Medium dose oral administration	Drug	treatment A, reference

Primary outcome

Empa: Area Under the Curve 0 to Infinity (AUC0-∞)
Time frame: 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
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.
Simvastatin: Area Under the Curve 0 to Infinity (AUC0-∞)
Time frame: 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
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.
Empa: Maximum Measured Concentration (Cmax)
Time frame: 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
Maximum measured concentration of the analyte in plasma, per period. The geometric mean and geometric coefficient of variation (gCV) are adjusted values
Simvastatin: Maximum Measured Concentration (Cmax)
Time frame: 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
Maximum measured concentration of the analyte in plasma, per period. The geometric mean and geometric coefficient of variation (gCV) are adjusted values.

2 secondary outcomes

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

Results and safety

Results posted to the registry on 28 Jul 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 Alone / Simvastatin Alone / Empa Plus Sim	3	3
Empa Alone / Empa Plus Sim / Simvastatin Alone	3	3
Simvastatin Alone / Empa Alone / Empa Plus Sim	3	3
Simvastatin Alone / Empa Plus Sim / Empa Alone	3	3
Empa Plus Sim / Empa Alone / Simvastatin Alone	3	3
Empa Plus Sim / Simvastatin Alone / Empa Alone	3	3

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

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

Measure	Empa Alone n = 18	Empa Plus Sim n = 18
Value	5571.70 (5.4)	5685.69 (5.4)

Empa Alone vs Empa Plus Sim: Geometric Mean Ratio: 102.05 (90% CI 98.90 to 105.29), ANOVA

Population analysed: Pharmacokinetic (PK) set: PK set included all evaluable subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of PK.

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

Measure	Simvastatin Alone n = 17	Empa Plus Sim n = 18
AUC of simvastatin	33.51 (40.4)	33.93 (40.4)
AUC of simvastatin acid	16.83 (25.5)	17.65 (25.5)

Simvastatin Alone vs Empa Plus Sim: Geometric Mean Ratio: 101.26 (90% CI 80.06 to 128.07), ANOVA
Simvastatin Alone vs Empa Plus Sim: Geometric Mean Ratio: 104.87 (90% CI 90.09 to 122.07), ANOVA

Primary outcome: Empa: Maximum Measured Concentration (Cmax)

Measure	Empa Alone n = 18	Empa Plus Sim n = 18
Value	774.06 (21.1)	847.49 (21.1)

Empa Alone vs Empa Plus Sim: Geometric Mean Ratio: 109.49 (90% CI 96.91 to 123.69), ANOVA

Primary outcome: Simvastatin: Maximum Measured Concentration (Cmax)

Measure	Simvastatin Alone n = 17	Empa Plus Sim n = 18
Cmax of simvastatin	7.88 (41.7)	7.65 (41.7)
Cmax of simvastatin acid	1.51 (22.7)	1.47 (22.7)

Simvastatin Alone vs Empa Plus Sim: Geometric Mean Ratio: 97.18 (90% CI 76.30 to 123.77), ANOVA
Simvastatin Alone vs Empa Plus Sim: Geometric Mean Ratio: 97.27 (90% CI 84.90 to 111.44), ANOVA

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: First administration of trial medication until next administration of trial medication or up to post-study visit, up to 36 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Empa Alone	0 of 18 (0%)	6 of 18 (33.3%)	Not reported
Simvastatin Alone	0 of 17 (0%)	4 of 17 (23.5%)	Not reported
Empa Plus Sim	0 of 18 (0%)	5 of 18 (27.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
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 BI 10773 and simvastatin 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 28 Jul 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 28 Jul 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?

Empa: Area Under the Curve 0 to Infinity (AUC0-∞) (time frame: 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). The study lists 4 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 NCT01304329.

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 28 Jul 2014.