HealthyPhase 1NCT02815644

Empa/Lina FDC Food Effect Study (Japan)

A Phase 1 study testing empagliflozin/linagliptin FDC in people with Healthy, run by Boehringer Ingelheim at 1 site in Japan.

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 trial will be performed as an open-label, randomised, single-dose, two-sequence crossover design for the assessment of effect of food on bioavailability of empagliflozin / linagliptin fixed dose combination (FDC) tablet. Read more about this study

Who is it for?: Ages 20 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: empagliflozin/linagliptin FDC
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 1 siteJapan
Study dates: 15 Jul 2016to 5 Oct 2016
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 20 to 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male subjects age >=20 and <=45 years; body weight: >=50 kg and <=80 kg; body mass index: >=18.0 and <=25.0 kg/m2
Without any clinically significant findings and complications on the basis of a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR), body temperature)
Signed and dated written informed consent prior to admission to the trial in accordance with the Good Clinical Practice (GCP) and the local legislation

Who cannot join

Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance
Further exclusion criteria apply

Trial locations and contacts

1 site in 1 country.

Japan1 site

SOUSEIKAI Sumida Hospital
Tokyo, Sumida-ku, 133-0004

Other trials in Japan

About this study

Official title: Investigation of the Effect of Food on the Bioavailability of Empagliflozin / Linagliptin Fixed Dose Combination Tablet in an Open, Randomised, Single Dose, Two Way Cross-over Study in Healthy Japanese Male Subjects

Conditions: Healthy
Being tested: empagliflozin/linagliptin FDC

What participants receive

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

empagliflozin/linagliptin FDCDrug
empagliflozin/linagliptin fixed-dose combination (FDC) film-coated tablet

Study groups in NCT02815644
Study group	Role	What they receive
empagliflozin/linagliptin FDC	Experimental	empagliflozin/linagliptin fixed-dose combination (FDC) film-coated tablet Receives: Drug: empagliflozin/linagliptin FDC

What is being measured

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

Cmax for Linagliptin
Maximum measured concentration of the analyte in plasma (Cmax) for linagliptin
Measured: 2 hours (h) before the administration in first subject and 0:20 h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, 72:00h after drug administration.
Cmax for Empagliflozin
Maximum measured concentration of the analyte in plasma (Cmax) for empagliflozin
Measured: 2 hours (h) before the administration in first subject and 0:20 h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, 72:00h after drug administration.
AUC 0-tz for Linagliptin
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable drug plasma concentration (AUC 0-tz) for linagliptin
Measured: 2 hours (h) before the administration in first subject and 0:20 h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, 72:00h after drug administration.
AUC 0-tz for Empagliflozin
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable drug plasma concentration (AUC 0-tz) for empagliflozin
Measured: 2 hours (h) before the administration in first subject and 0:20 h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, 72:00h after drug administration.

Secondary outcomes (3)

AUC0-infinity for Linagliptin
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity) for linagliptin
Measured: 2 hours (h) before the administration in first subject and 0:20 h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, 72:00h after drug administration.
AUC0-infinity for Empagliflozin
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity) for empagliflozin.
Measured: 2 hours (h) before the administration in first subject and 0:20 h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, 72:00h after drug administration.
AUC0-72 for Linagliptin
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 72 hours (AUC0-72) for linagliptin
Measured: 2 hours (h) before the administration in first subject and 0:20 h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, 72:00h after drug administration.

Timeline

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

15 Jul 20165 Oct 2016

First posted28 Jun 2016 (estimated)
Study start15 Jul 2016
Primary completion5 Oct 2016
Study completion5 Oct 2016

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: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02815644
Sponsor's protocol ID: 1275.17
Status last verified: Oct 2017
First submitted: 24 Jun 2016
Last updated: 16 Aug 2018
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 16 Aug 2018. 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 Empagliflozin / Linagliptin Fixed Dose Combination Tablet in an Open, Randomised, Single Dose, Two Way Cross-over Study in Healthy Japanese Male Subjects
ClinicalTrials.gov ID: NCT02815644
Acronym / sponsor ID: 1275.17
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 15 Jul 2016 (actual)
Primary completion: 5 Oct 2016 (actual)
Study completion: 5 Oct 2016 (actual)
First posted: 28 Jun 2016 (estimated)
Results: Posted 16 Aug 2018

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
empagliflozin/linagliptin FDC	Experimental	Drug: empagliflozin/linagliptin FDCempagliflozin/linagliptin fixed-dose combination (FDC) film-coated tablet

Who may qualify

Ages: 20 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Healthy male subjects age >=20 and <=45 years; body weight: >=50 kg and <=80 kg; body mass index: >=18.0 and <=25.0 kg/m2
Without any clinically significant findings and complications on the basis of a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR), body temperature)
Signed and dated written informed consent prior to admission to the trial in accordance with the Good Clinical Practice (GCP) and the local legislation

Key exclusion criteria (2 listed)

Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance
Further exclusion criteria apply

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
empagliflozin/linagliptin FDCempagliflozin/linagliptin fixed-dose combination (FDC) film-coated tablet	Drug	empagliflozin/linagliptin FDC

Primary outcome

Cmax for Linagliptin
Time frame: 2 hours (h) before the administration in first subject and 0:20 h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, 72:00h after drug administration.
Maximum measured concentration of the analyte in plasma (Cmax) for linagliptin
Cmax for Empagliflozin
Time frame: 2 hours (h) before the administration in first subject and 0:20 h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, 72:00h after drug administration.
Maximum measured concentration of the analyte in plasma (Cmax) for empagliflozin
AUC 0-tz for Linagliptin
Time frame: 2 hours (h) before the administration in first subject and 0:20 h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, 72:00h after drug administration.
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable drug plasma concentration (AUC 0-tz) for linagliptin
AUC 0-tz for Empagliflozin
Time frame: 2 hours (h) before the administration in first subject and 0:20 h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, 72:00h after drug administration.
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable drug plasma concentration (AUC 0-tz) for empagliflozin

3 secondary outcomes

AUC0-infinity for Linagliptin
Time frame: 2 hours (h) before the administration in first subject and 0:20 h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, 72:00h after drug administration.
AUC0-infinity for Empagliflozin
Time frame: 2 hours (h) before the administration in first subject and 0:20 h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, 72:00h after drug administration.
AUC0-72 for Linagliptin
Time frame: 2 hours (h) before the administration in first subject and 0:20 h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, 72:00h after drug administration.

Results and safety

Results posted to the registry on 16 Aug 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Empagliflozin 25 mg/ Linagliptin 5 mg (Sequence 1: Fed-Fasted)	11	11
Empagliflozin 25 mg/ Linagliptin 5 mg (Sequence 2: Fasted-Fed)	11	11

Primary outcome: Cmax for Linagliptin

Time frame: 2 hours (h) before the administration in first subject and 0:20 h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, 72:00h after drug administration.. Geometric mean (Geometric Coefficient of Variation). Unit: nmol/L

Measure	Empagliflozin 25 mg/ Linagliptin 5 mg (Reference;Fasted) n = 22	Empagliflozin 25 mg/ Linagliptin 5 mg (Test;Fed) n = 22
Value	15.1 (50.6)	8.43 (30.3)

Empagliflozin 25 mg/ Linagliptin 5 mg (Reference;Fasted) vs Empagliflozin 25 mg/ Linagliptin 5 mg (Test;Fed): T/R ratio: 55.69 (90% CI 48.22 to 64.33)

Population analysed: Pharmacokinetic Set (PKS): The PKS included all 22 randomised subjects who were documented to have taken at least 1 dose of trial medication under fed or fasted condition without having protocol deviation relevant to the evaluation of relative bioavailability and without experiencing emesis at or before 2 times median tmax.

Primary outcome: Cmax for Empagliflozin

Measure	Empagliflozin 25 mg/ Linagliptin 5 mg (Reference;Fasted) n = 22	Empagliflozin 25 mg/ Linagliptin 5 mg (Test;Fed) n = 22
Value	1010 (27.1)	756 (27.3)

Empagliflozin 25 mg/ Linagliptin 5 mg (Reference;Fasted) vs Empagliflozin 25 mg/ Linagliptin 5 mg (Test;Fed): T/R ratio: 74.89 (90% CI 66.27 to 84.64)

Population analysed: PKS

Primary outcome: AUC 0-tz for Linagliptin

Measure	Empagliflozin 25 mg/ Linagliptin 5 mg (Reference;Fasted) n = 22	Empagliflozin 25 mg/ Linagliptin 5 mg (Test;Fed) n = 22
Value	348 (15.4)	286 (20.5)

Empagliflozin 25 mg/ Linagliptin 5 mg (Reference;Fasted) vs Empagliflozin 25 mg/ Linagliptin 5 mg (Test;Fed): T/R ratio: 82.19 (90% CI 78.38 to 86.18)

Population analysed: PKS

Primary outcome: AUC 0-tz for Empagliflozin

Measure	Empagliflozin 25 mg/ Linagliptin 5 mg (Reference;Fasted) n = 22	Empagliflozin 25 mg/ Linagliptin 5 mg (Test;Fed) n = 22
Value	7210 (19.1)	6200 (20.6)

Empagliflozin 25 mg/ Linagliptin 5 mg (Reference;Fasted) vs Empagliflozin 25 mg/ Linagliptin 5 mg (Test;Fed): T/R ratio: 85.99 (90% CI 83.38 to 88.68)

Population analysed: PKS

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first drug administration until 7 days thereafter for each treatment arm, up to 8 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Empagliflozin 25 mg/ Linagliptin 5 mg (Reference;Fasted)	0 of 22 (0%)	0 of 22 (0%)	Not reported
Empagliflozin 25 mg/ Linagliptin 5 mg (Test;Fed)	0 of 22 (0%)	0 of 22 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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/linagliptin FDC in people with Healthy, run by Boehringer Ingelheim at 1 site in Japan.

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 3 inclusion and 2 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 16 Aug 2018. 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 Japan. 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 16 Aug 2018). 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?

Cmax for Linagliptin (time frame: 2 hours (h) before the administration in first subject and 0:20 h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, 72:00h 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 NCT02815644.

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 16 Aug 2018.