HealthyPhase 1NCT01451775

Investigation of the Effect of Food on the Bioavailability of a 25 mg Empagliflozin Tablet as Well as Assessment of Dose Proportionality Between 10 mg and 25 mg Empagliflozin Tablets Under Fasting Conditions.

A Phase 1 study testing Empagliflozin 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.

Trial summary

Investigation of food effect on the bioavailability of a 25 mg empagliflozin tablet and assessment of dose proportionality between 10 mg and 25 mg empagliflozin tablets under fasting conditions. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Empagliflozin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteGermany
Study dates: Oct 2011to Nov 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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

1. Healthy male and female subjects

Who cannot join

1. Any relevant deviation from healthy conditions

Trial locations and contacts

1 site in 1 country.

Germany1 site

1245.79.1 Boehringer Ingelheim Investigational Site
Biberach

Other trials in Germany

About this study

Official title: Investigation of the Effect of Food on the Bioavailability of a 25 mg Empagliflozin Tablet and Assessment of Dose Proportionality Between 10 mg and 25 mg Empagliflozin Tablets in an Open, Randomised, Single Dose, Three-period Cross-over Study in Healthy Male and Female Subjects

Investigation of food effect on the bioavailability of a 25 mg empagliflozin tablet and assessment of dose proportionality between 10 mg and 25 mg empagliflozin tablets under fasting conditions.

Conditions: Healthy
Being tested: Empagliflozin

What participants receive

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

EmpagliflozinDrug
high dose of empagliflozin after overnight fasting for at least 10 h
EmpagliflozinDrug
low dose empagliflozin after overnight fasting for at least 10 h
EmpagliflozinDrug
high dose of empagliflozin after a standardised high fat breakfast

Study groups in NCT01451775
Study group	Role	What they receive
Treatment A	Experimental	high dose of empagliflozin after overnight fasting for at least 10 h Receives: Drug: Empagliflozin
Treatment B	Experimental	high dose of empagliflozin after a standardised high fat breakfast Receives: Drug: Empagliflozin
Treatment C	Experimental	low dose empagliflozin after overnight fasting for at least 10 h Receives: Drug: Empagliflozin

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 (empa) in plasma over the time interval from 0 hours extrapolated to infinity (AUC0-∞).
The Measured Values show intra-arm variabilities, whereas the statistical analyses show inter-arm variabilities.
Measured: 1 hour (h) before study drug and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration
Maximum Measured Concentration (Cmax)
Maximum measured concentration of empagloflozin (empa) in plasma, per period.
The Measured Values show intra-arm variabilities, whereas the statistical analyses show inter-arm variabilities.
Measured: 1 hour (h) before study drug and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration

Secondary outcomes (1)

Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Clinical Laboratory Tests and Assessment of Tolerability by the Investigator.
Clinically relevant abnormalities for physical examination, vital signs, ECG, blood chemistry, haematology, urinanalysis and assessment of tolerability by the investigator. New abnormal findings or worsening of baseline conditions were reported as adverse events (AEs). Time frame for AE reporting includes the period of first drug administration until end of study. A more detailed definition of the used time frame and MedDRA Version can be found in the AE section.
Measured: Screening until end of trial, average of 45 days

Timeline

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

Oct 2011Nov 2011

First posted14 Oct 2011 (estimated)
Study startOct 2011
Primary completionNov 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: NCT01451775
Sponsor's protocol ID: 1245.79
Other IDs: 2011-002836-13
Status last verified: Jun 2014
First submitted: 11 Oct 2011
Last updated: 27 Jun 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?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Investigation of the Effect of Food on the Bioavailability of a 25 mg Empagliflozin Tablet and Assessment of Dose Proportionality Between 10 mg and 25 mg Empagliflozin Tablets in an Open, Randomised, Single Dose, Three-period Cross-over Study in Healthy Male and Female Subjects
ClinicalTrials.gov ID: NCT01451775
Acronym / sponsor ID: 1245.79
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Oct 2011
Primary completion: Nov 2011 (actual)
First posted: 14 Oct 2011 (estimated)
Results: Posted 27 Jun 2014

Clinical summary

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

Investigation of food effect on the bioavailability of a 25 mg empagliflozin tablet and assessment of dose proportionality between 10 mg and 25 mg empagliflozin tablets under fasting conditions.

Study design

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

Arm	Type	Receives
Treatment A	Experimental	Drug: Empagliflozinhigh dose of empagliflozin after overnight fasting for at least 10 h
Treatment B	Experimental	Drug: Empagliflozinhigh dose of empagliflozin after a standardised high fat breakfast
Treatment C	Experimental	Drug: Empagliflozinlow dose empagliflozin after overnight fasting for at least 10 h

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

1. Healthy male and female subjects

Key exclusion criteria (1 listed)

1. 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
Empagliflozinhigh dose of empagliflozin after overnight fasting for at least 10 h	Drug	Treatment A
Empagliflozinlow dose empagliflozin after overnight fasting for at least 10 h	Drug	Treatment C
Empagliflozinhigh dose of empagliflozin after a standardised high fat breakfast	Drug	Treatment B

Primary outcome

Area Under the Curve 0 to Infinity (AUC0-∞)
Time frame: 1 hour (h) before study drug and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration
Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 hours extrapolated to infinity (AUC0-∞). The Measured Values show intra-arm variabilities, whereas the statistical analyses show inter-arm variabilities.
Maximum Measured Concentration (Cmax)
Time frame: 1 hour (h) before study drug and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration
Maximum measured concentration of empagloflozin (empa) in plasma, per period. The Measured Values show intra-arm variabilities, whereas the statistical analyses show inter-arm variabilities.

1 secondary outcome

Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Clinical Laboratory Tests and Assessment of Tolerability by the Investigator.
Time frame: Screening until end of trial, average of 45 days

Results and safety

Results posted to the registry on 27 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 25mg Fasted / Empa 25mg Fed / Empa 10mg Fasted	3	3
Empa 25mg Fasted / Empa 10mg Fasted / Empa 25mg Fed	3	3
Empa 25mg Fed / Empa 25mg Fasted / Empa 10mg Fasted	3	3
Empa 25mg Fed / Empa 10mg Fasted / Empa 25mg Fasted	3	3
Empa 10mg Fasted / Empa 25mg Fasted / Empa 25mg Fed	3	3
Empa 10mg Fasted / Empa 25mg Fed / Empa 25mg Fasted	3	3

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

Time frame: 1 hour (h) before study drug and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration. Geometric mean (Geometric Coefficient of Variation). Unit: nmol*h/L

Measure	Empa 25 mg Fasted n = 18	Empa 25 mg Fed n = 17	Empa 10 mg Fasted n = 18
Value	5380 (26.0)	4520 (24.8)	2280 (27.0)

Empa 25 mg Fasted vs Empa 25 mg Fed: Geometric mean ratio: 84.04 (90% CI 80.856 to 87.344), ANOVA
Empa 25 mg Fasted vs Empa 10 mg Fasted: Slope: 0.9367 (95% CI 0.8988 to 0.9746), ANCOVA

Population analysed: All treated subjects who provided at least one observation in the relevant treatment periods for at least one primary pharmacokinetic (PK) endpoint without a relevant protocol deviation and who had not experienced emesis before or at 2 times median tmax in at least one of the two relevant treatment periods.

Primary outcome: Maximum Measured Concentration (Cmax)

Measure	Empa 25 mg Fasted n = 18	Empa 25 mg Fed n = 17	Empa 10 mg Fasted n = 18
Value	837 (27.8)	523 (27.7)	365 (27.7)

Empa 25 mg Fasted vs Empa 25 mg Fed: Geometric mean ratio: 63.22 (90% CI 56.736 to 70.439), ANOVA
Empa 25 mg Fasted vs Empa 10 mg Fasted: Slope: 0.9065 (95% CI 0.8011 to 1.0120), ANCOVA

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Drug administration until beginning of next sequence/end of trial, average of 24 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Empa 25 mg Fasted	0 of 18 (0%)	2 of 18 (11.1%)	Not reported
Empa 25 mg Fed	0 of 18 (0%)	2 of 18 (11.1%)	Not reported
Empa 10 mg Fasted	0 of 18 (0%)	4 of 18 (22.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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 Empagliflozin 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 27 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 27 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: 1 hour (h) before study drug and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 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 NCT01451775.

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 27 Jun 2014.