HealthyPhase 1NCT02783040

Interaction of BI 425809 With Midazolam, Warfarin, Omeprazole and Digoxin

A Phase 1 study testing Midazolam, Warfarin and Omeprazole 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

To assess the influence of multiple doses of BI 425809 on single dose pharmacokinetics of midazolam (CYP3A4 probe drug), warfarin (CYP2C9 probe drug), omeprazole (CYP2C19 probe drug) and digoxin (P-gp probe drug) Read more about this study

Who is it for?: Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Midazolam, Warfarin and Omeprazole
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 13 participants
Where: 1 siteGermany
Study dates: 7 Sep 2015to 30 Oct 2015
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
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male subjects according to the investigators assessment, based on a complete medical history including a physical examination, vital signs (blood pressure (BP), puls rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
Age of 18 to 55 years (incl.)
Body Mass Index (BMI) of 18.5 to 29.9 kg/m2 (incl.)
Signed and dated written informed consent prior to admission to the study in accordance with good clinical practice (GCP) and local legislation
Ready and able to use highly effective methods of birth control that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the subject information

Who cannot join

Any finding in the medical examination (including blood pressure (BP), puls rate (PR) or electrocardiogram (ECG)) is deviating from normal and judged as clinically relevant by the investigator
Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
Any evidence of a concomitant disease judged as clinically relevant by the investigator
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)
Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders Further exclusion criteria apply

Trial locations and contacts

1 site in 1 country.

Germany1 site

1346.22.1 Boehringer Ingelheim Investigational Site
Biberach

Other trials in Germany

About this study

Official title: A Study to Investigate the Effects of Multiple Doses of BI 425809 on the Single Dose Pharmacokinetics of Cytochrome P450 Substrates (Midazolam, Warfarin and Omeprazole) and a P Glycoprotein Substrate (Digoxin) Administered Orally in an Open-label, One-sequence Trial in Healthy Male Subjects

Conditions: Healthy
Being tested: Midazolam, Warfarin, Omeprazole, Digoxin, BI 425809

What participants receive

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

MidazolamDrug
WarfarinDrug
OmeprazoleDrug
DigoxinDrug
BI 425809Drug
Also called Iclepertin
Tablet

Study groups in NCT02783040
Study group	Role	What they receive
Probe drugs (Reference (R))/BI 425809+Probe drugs (Test (T))	Experimental	Not described Receives: Drug: Midazolam; Drug: Warfarin; Drug: Omeprazole; Drug: Digoxin; Drug: BI 425809

What is being measured

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

Area Under the Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Area under the concentration-time curve of midazolam in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is presented.
Time frame description:
Arm "Treatment period 1: Probe drugs": Within 2 hours before and 0.5 hour (h), 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h and 24 h after administration of probe drug cocktail on Day 1 of Treatment Period 1.
Arm "Treatment period 2: Short-term BI 425809 (after 3rd dose) plus midazolam": Within 3 hours before and 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of midazolam on Day 3 of Treatment Period 2.
Arm "Treatment period 2: Steady state BI 425809 plus probe drugs": Within 3 hours before and 0.5 h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h and 24 h after administration of probe drug cocktail on Day 10 of Treatment Period 2.
Measured: Within 3 h before and up to 24h after administration of midazolam/probe drug cocktail. For detailed timeframe please see outcome measure description.
Area Under the Concentration-time Curve of Omeprazole in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Area under the concentration-time curve of omeprazole in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is presented.
Arm "Treatment period 1: Probe drugs": Within 2 hours before and 0.5 hour (h), 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h and 24 h after administration of probe drug cocktail on Day 1 of Treatment Period 1.
Arm "Treatment period 2: Steady state BI 425809 plus probe drugs": Within 3 hours before and 0.5 h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h and 24 h after administration of probe drug cocktail on Day 10 of Treatment Period 2.
Measured: Within 3 h before and up to 24h after administration of probe drug cocktail. For detailed timeframe please see outcome measure description.
Area Under the Concentration-time Curve of S-warfarin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Area under the concentration-time curve of S-warfarin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is presented.
Arm "Treatment period 1: Probe drugs": Within 2 hours before and 0.5 hour (h), 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h and 24 h after administration of probe drug cocktail on Day 1 of Treatment Period 1.
Arm "Treatment period 2: Steady state BI 425809 plus probe drugs": Within 3 hours before and 0.5 h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h and 24 h after administration of probe drug cocktail on Day 10 of Treatment Period 2.
Measured: Within 3 h before and up to 24h after administration of probe drug cocktail. For detailed timeframe please see outcome measure description.
Area Under the Concentration-time Curve of Digoxin From 0 to the Time of the Last Quantifiable Data Point (AUC0-tz)
Area under the concentration-time curve of digoxin from 0 to the time of the last quantifiable data point (AUC0-tz) is presented.
Time frame description:
Arm "Treatment period 1: Probe drugs": Within 10 minutes before and 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 47h, 71h, 95h after digoxin administration on Day 2 of Treatment Period 1.
Arm "Treatment period 2: Steady state BI 425809 plus probe drugs": Within 4 hours before and 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 47h, 71h, 95h after digoxin administration on Day 11 of Treatment Period 2.
Measured: Blood sampling was done before and up to 95 after administration of digoxin. For detailed timeframe please see outcome measure description.
Maximum Concentration of Midazolam in Plasma (Cmax)
Maximum measured concentration of midazolam in plasma (Cmax) is presented.
Time frame description:
Arm "Treatment period 1: Probe drugs": Within 2 hours before and 0.5 hour (h), 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h and 24 h after administration of probe drug cocktail on Day 1 of Treatment Period 1.
Arm "Treatment period 2: Short-term BI 425809 (after 3rd dose) plus midazolam": Within 3 hours before and 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of midazolam on Day 3 of Treatment Period 2.
Arm "Treatment period 2: Steady state BI 425809 plus probe drugs": Within 3 hours before and 0.5 h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h and 24 h after administration of probe drug cocktail on Day 10 of Treatment Period 2.
Measured: Within 3 h before and up to 24h after administration of midazolam/probe drug cocktail. For detailed timeframe please see outcome measure description.
Maximum Concentration of Omeprazole in Plasma (Cmax)
Maximum measured concentration of omeprazole in plasma (Cmax) is presented. Arm "Treatment period 1: Probe drugs": Within 2 hours before and 0.5 hour (h), 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h and 24 h after administration of probe drug cocktail on Day 1 of Treatment Period 1.
Arm "Treatment period 2: Steady state BI 425809 plus probe drugs": Within 3 hours before and 0.5 h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h and 24 h after administration of probe drug cocktail on Day 10 of Treatment Period 2.
Measured: Within 3 h before and up to 24h after administration of probe drug cocktail. For detailed timeframe please see outcome measure description.
Maximum Concentration of S-warfarin in Plasma (Cmax)
Maximum measured concentration of S-warfarin in plasma (Cmax) is presented. Arm "Treatment period 1: Probe drugs": Within 2 hours before and 0.5 hour (h), 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h and 24 h after administration of probe drug cocktail on Day 1 of Treatment Period 1.
Arm "Treatment period 2: Steady state BI 425809 plus probe drugs": Within 3 hours before and 0.5 h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h and 24 h after administration of probe drug cocktail on Day 10 of Treatment Period 2.
Measured: Within 3 h before and up to 24h after administration of probe drug cocktail. For detailed timeframe please see outcome measure description.
Maximum Concentration of Digoxin in Plasma (Cmax)
Maximum measured concentration of digoxin in plasma (Cmax) is presented.
Time frame description:
Arm "Treatment period 1: Probe drugs": Within 10 minutes before and 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 47h, 71h, 95h after digoxin administration on Day 2 of Treatment Period 1.
Arm "Treatment period 2: Steady state BI 425809 plus probe drugs": Within 4 hours before and 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 47h, 71h, 95h after digoxin administration on Day 11 of Treatment Period 2.
Measured: Blood sampling was done before and up to 95 after administration of digoxin. For detailed timeframe please see outcome measure description.

Timeline

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

7 Sep 201530 Oct 2015

First posted26 May 2016 (estimated)
Study start7 Sep 2015
Primary completion30 Oct 2015
Study completion30 Oct 2015

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: Not applicable
Intervention model: Crossover
Model description: Participants administered first probe drugs during the reference period and BI 425809 + Probe drugs during the test period.
Masking: None (open label)
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02783040
Sponsor's protocol ID: 1346.22
Other IDs: 2015-001371-41, 2015
Status last verified: Apr 2026
First submitted: 23 Mar 2016
Last updated: 15 Apr 2026
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases(in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing

Publications

Desch M, Schlecker C, Hohl K, Liesenfeld KH, Chan T, Muller F, Wunderlich G, Keller S, Ishiguro N, Wind S. Pharmacokinetic-Interactions of BI 425809, a Novel Glycine Transporter 1 Inhibitor, With Cytochrome P450 and P-Glycoprotein Substrates: Findings From In Vitro Analyses and an Open-Label, Single-Sequence Phase I Study. J Clin Psychopharmacol. 2023 Mar-Apr 01;43(2):113-121. doi: 10.1097/JCP.0000000000001656. Epub 2023 Jan 26.
PubMed 36700734

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 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Investigate the Effects of Multiple Doses of BI 425809 on the Single Dose Pharmacokinetics of Cytochrome P450 Substrates (Midazolam, Warfarin and Omeprazole) and a P Glycoprotein Substrate (Digoxin) Administered Orally in an Open-label, One-sequence Trial in Healthy Male Subjects
ClinicalTrials.gov ID: NCT02783040
Acronym / sponsor ID: 1346.22
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 13 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 7 Sep 2015 (actual)
Primary completion: 30 Oct 2015 (actual)
Study completion: 30 Oct 2015 (actual)
First posted: 26 May 2016 (estimated)
Results: Posted 15 Apr 2026

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: Not applicable
Intervention model: Crossover
Masking: None (open label)
Number of arms: 1
Model description: Participants administered first probe drugs during the reference period and BI 425809 + Probe drugs during the test period.

Arm	Type	Receives
Probe drugs (Reference (R))/BI 425809+Probe drugs (Test (T))	Experimental	Drug: Midazolam, Drug: Warfarin, Drug: Omeprazole, Drug: Digoxin, Drug: BI 425809

Who may qualify

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

Key inclusion criteria (5 listed)

Healthy male subjects according to the investigators assessment, based on a complete medical history including a physical examination, vital signs (blood pressure (BP), puls rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
Age of 18 to 55 years (incl.)
Body Mass Index (BMI) of 18.5 to 29.9 kg/m2 (incl.)
Signed and dated written informed consent prior to admission to the study in accordance with good clinical practice (GCP) and local legislation
Ready and able to use highly effective methods of birth control that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the subject information

Key exclusion criteria (7 listed)

Any finding in the medical examination (including blood pressure (BP), puls rate (PR) or electrocardiogram (ECG)) is deviating from normal and judged as clinically relevant by the investigator
Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
Any evidence of a concomitant disease judged as clinically relevant by the investigator
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders

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
Midazolam	Drug	Probe drugs (Reference (R))/BI 425809+Probe drugs (Test (T))
Warfarin	Drug	Probe drugs (Reference (R))/BI 425809+Probe drugs (Test (T))
Omeprazole	Drug	Probe drugs (Reference (R))/BI 425809+Probe drugs (Test (T))
Digoxin	Drug	Probe drugs (Reference (R))/BI 425809+Probe drugs (Test (T))
BI 425809Also: IclepertinTablet	Drug	Probe drugs (Reference (R))/BI 425809+Probe drugs (Test (T))

Primary outcome

Area Under the Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Time frame: Within 3 h before and up to 24h after administration of midazolam/probe drug cocktail. For detailed timeframe please see outcome measure description.
Area under the concentration-time curve of midazolam in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is presented. Time frame description: Arm "Treatment period 1: Probe drugs": Within 2 hours before and 0.5 hour (h), 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h and 24 h after administration of probe drug cocktail on Day 1 of Treatment Period 1. Arm "Treatment period 2: Short-term BI 425809 (after 3rd dose) plus midazolam": Within 3 hours before and 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of midazolam on Day 3 of Treatment Period 2. Arm "Treatment period 2: Steady state BI 425809 plus probe drugs": Within 3 hours before and 0.5 h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h and 24 h after administration of probe drug cocktail on Day 10 of Treatment Period 2.
Area Under the Concentration-time Curve of Omeprazole in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Time frame: Within 3 h before and up to 24h after administration of probe drug cocktail. For detailed timeframe please see outcome measure description.
Area under the concentration-time curve of omeprazole in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is presented. Arm "Treatment period 1: Probe drugs": Within 2 hours before and 0.5 hour (h), 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h and 24 h after administration of probe drug cocktail on Day 1 of Treatment Period 1. Arm "Treatment period 2: Steady state BI 425809 plus probe drugs": Within 3 hours before and 0.5 h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h and 24 h after administration of probe drug cocktail on Day 10 of Treatment Period 2.
Area Under the Concentration-time Curve of S-warfarin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Time frame: Within 3 h before and up to 24h after administration of probe drug cocktail. For detailed timeframe please see outcome measure description.
Area under the concentration-time curve of S-warfarin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is presented. Arm "Treatment period 1: Probe drugs": Within 2 hours before and 0.5 hour (h), 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h and 24 h after administration of probe drug cocktail on Day 1 of Treatment Period 1. Arm "Treatment period 2: Steady state BI 425809 plus probe drugs": Within 3 hours before and 0.5 h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h and 24 h after administration of probe drug cocktail on Day 10 of Treatment Period 2.
Area Under the Concentration-time Curve of Digoxin From 0 to the Time of the Last Quantifiable Data Point (AUC0-tz)
Time frame: Blood sampling was done before and up to 95 after administration of digoxin. For detailed timeframe please see outcome measure description.
Area under the concentration-time curve of digoxin from 0 to the time of the last quantifiable data point (AUC0-tz) is presented. Time frame description: Arm "Treatment period 1: Probe drugs": Within 10 minutes before and 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 47h, 71h, 95h after digoxin administration on Day 2 of Treatment Period 1. Arm "Treatment period 2: Steady state BI 425809 plus probe drugs": Within 4 hours before and 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 47h, 71h, 95h after digoxin administration on Day 11 of Treatment Period 2.
Maximum Concentration of Midazolam in Plasma (Cmax)
Time frame: Within 3 h before and up to 24h after administration of midazolam/probe drug cocktail. For detailed timeframe please see outcome measure description.
Maximum measured concentration of midazolam in plasma (Cmax) is presented. Time frame description: Arm "Treatment period 1: Probe drugs": Within 2 hours before and 0.5 hour (h), 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h and 24 h after administration of probe drug cocktail on Day 1 of Treatment Period 1. Arm "Treatment period 2: Short-term BI 425809 (after 3rd dose) plus midazolam": Within 3 hours before and 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of midazolam on Day 3 of Treatment Period 2. Arm "Treatment period 2: Steady state BI 425809 plus probe drugs": Within 3 hours before and 0.5 h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h and 24 h after administration of probe drug cocktail on Day 10 of Treatment Period 2.
Maximum Concentration of Omeprazole in Plasma (Cmax)
Time frame: Within 3 h before and up to 24h after administration of probe drug cocktail. For detailed timeframe please see outcome measure description.
Maximum measured concentration of omeprazole in plasma (Cmax) is presented. Arm "Treatment period 1: Probe drugs": Within 2 hours before and 0.5 hour (h), 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h and 24 h after administration of probe drug cocktail on Day 1 of Treatment Period 1. Arm "Treatment period 2: Steady state BI 425809 plus probe drugs": Within 3 hours before and 0.5 h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h and 24 h after administration of probe drug cocktail on Day 10 of Treatment Period 2.
Maximum Concentration of S-warfarin in Plasma (Cmax)
Time frame: Within 3 h before and up to 24h after administration of probe drug cocktail. For detailed timeframe please see outcome measure description.
Maximum measured concentration of S-warfarin in plasma (Cmax) is presented. Arm "Treatment period 1: Probe drugs": Within 2 hours before and 0.5 hour (h), 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h and 24 h after administration of probe drug cocktail on Day 1 of Treatment Period 1. Arm "Treatment period 2: Steady state BI 425809 plus probe drugs": Within 3 hours before and 0.5 h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h and 24 h after administration of probe drug cocktail on Day 10 of Treatment Period 2.
Maximum Concentration of Digoxin in Plasma (Cmax)
Time frame: Blood sampling was done before and up to 95 after administration of digoxin. For detailed timeframe please see outcome measure description.
Maximum measured concentration of digoxin in plasma (Cmax) is presented. Time frame description: Arm "Treatment period 1: Probe drugs": Within 10 minutes before and 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 47h, 71h, 95h after digoxin administration on Day 2 of Treatment Period 1. Arm "Treatment period 2: Steady state BI 425809 plus probe drugs": Within 4 hours before and 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 47h, 71h, 95h after digoxin administration on Day 11 of Treatment Period 2.

Results and safety

Results posted to the registry on 15 Apr 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Probe Drugs (Reference (R))/BI 425809+Probe Drugs (Test (T))	13	12

Primary outcome: Area Under the Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)

Time frame: Within 3 h before and up to 24h after administration of midazolam/probe drug cocktail. For detailed timeframe please see outcome measure description.. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram (ng)*hour (h)/millilitre (mL)

Measure	Treatment Period 2: Short-term BI 425809 (After 3rd Dose) Plus Midazolam n = 12	Treatment Period 1: Probe Drugs n = 13	Treatment Period 2: BI 425809 Plus Probe Drugs n = 12
Value	19.0 (40.8)	23.5 (33.4)	16.0 (29.3)

Treatment Period 2: Short-term BI 425809 (After 3rd Dose) Plus Midazolam vs Treatment Period 1: Probe Drugs: Adjusted gMean ratio [%]: 84.20 (90% CI 76.8 to 92.32)
Treatment Period 1: Probe Drugs vs Treatment Period 2: BI 425809 Plus Probe Drugs: Adjusted gMean ratio [%]: 70.63 (90% CI 63.85 to 78.13)

Population analysed: Pharmacokinetic Analysis Set (PKS): All subjects in the Treated Set (TS) who provided at least 1 primary Pharmacokinetic (PK) endpoint value not flagged for exclusion, e.g. due to PK non-evaluability or a protocol violation relevant to the evaluation of PK endpoints; the PKS was used for analyses of the primary and the further PK endpoints.

Primary outcome: Area Under the Concentration-time Curve of Omeprazole in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)

Time frame: Within 3 h before and up to 24h after administration of probe drug cocktail. For detailed timeframe please see outcome measure description.. Geometric mean (Geometric Coefficient of Variation). Unit: ng*h/mL

Measure	Treatment Period 2: BI 425809 Plus Probe Drugs n = 12	Treatment Period 1: Probe Drugs n = 13
Value	384 (118)	483 (128)

Treatment Period 2: BI 425809 Plus Probe Drugs vs Treatment Period 1: Probe Drugs: Adjusted gMean ratio [%]: 88.94 (90% CI 81.02 to 97.63)

Population analysed: Pharmacokinetic Analysis Set (PKS): All subjects in the Treated Set (TS) who provided at least 1 primary PK endpoint value not flagged for exclusion, e.g. due to PK non-evaluability or a protocol violation relevant to the evaluation of PK endpoints; the PKS was used for analyses of the primary and the further PK endpoints.

Primary outcome: Area Under the Concentration-time Curve of S-warfarin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)

Measure	Treatment Period 2: BI 425809 Plus Probe Drugs n = 12	Treatment Period 1: Probe Drugs n = 12
Value	15200 (22.6)	15100 (21.4)

Treatment Period 2: BI 425809 Plus Probe Drugs vs Treatment Period 1: Probe Drugs: Adjusted gMean ratio [%]: 100.64 (90% CI 97.15 to 104.26)

Primary outcome: Area Under the Concentration-time Curve of Digoxin From 0 to the Time of the Last Quantifiable Data Point (AUC0-tz)

Time frame: Blood sampling was done before and up to 95 after administration of digoxin. For detailed timeframe please see outcome measure description.. Geometric mean (Geometric Coefficient of Variation). Unit: ng*h/mL

Measure	Treatment Period 2: BI 425809 Plus Probe Drugs n = 12	Treatment Period 1: Probe Drugs n = 12
Value	9.51 (37.0)	9.71 (38.4)

Treatment Period 2: BI 425809 Plus Probe Drugs vs Treatment Period 1: Probe Drugs: Adjusted gMean ratio [%]: 97.88 (90% CI 86.61 to 110.62)

Adverse events

Time frame: From first drug administration until at least 11 days after last drug administration for each treatment arm, up to 36 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment Period 1: Probe Drugs	0 of 13 (0%)	4 of 13 (30.8%)	Not reported
Treatment Period 2: BI 425809 Plus Probe Drugs	0 of 12 (0%)	11 of 12 (91.7%)	Not reported
Overall Treatment	0 of 13 (0%)	13 of 13 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36700734Desch M, Schlecker C, Hohl K, Liesenfeld KH, Chan T, Muller F, Wunderlich G, Keller S, Ishiguro N, Wind S. Pharmacokinetic-Interactions of BI 425809, a Novel Glycine Transporter 1 Inhibitor, With Cytochrome P450 and P-Glycoprotein Substrates: Findings From In Vitro Analyses and an Open-Label, Single-Sequence Phase I Study. J Clin Psychopharmacol. 2023 Mar-Apr 01;43(2):113-121. doi: 10.1097/JCP.0000000000001656. Epub 2023 Jan 26.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases(in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing

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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 Midazolam, Warfarin and Omeprazole 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 5 inclusion and 7 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 15 Apr 2026. 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 15 Apr 2026). 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 Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) (time frame: Within 3 h before and up to 24h after administration of midazolam/probe drug cocktail. For detailed timeframe please see outcome measure description.). The study lists 8 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 NCT02783040, 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 15 Apr 2026.