HealthyPhase 1NCT03082183

A Study in Healthy Men to Test Whether Rifampicin Influences the Amount of BI 425809 in the Blood

A Phase 1 study testing Rifampicin and BI 425809 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 primary objective of this trial is to investigate the relative bioavailability of a single dose of BI 425809 when given alone (Reference, B) compared with co-administration (Test, A) on the 7th day of a 10-day treatment with rifampicin following oral administration in healthy male volunteers. 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?: Rifampicin and BI 425809
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteGermany
Study dates: 28 Mar 2017to 20 Jun 2017
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 assessment of the investigator, based on a complete medical history including a physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
Age of 18 to 55 years (incl.)
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

Who cannot join

Any finding in the medical examination (including Blood Pressure (BP), Pulse 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)

Show all 23Show fewer

Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
History of relevant orthostatic hypotension, fainting spells, or blackouts
Chronic or relevant acute infections
History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)
Use of drugs within 30 days prior to administration of trial medication if that might reasonably influence the results of the trial (incl. QT/QTc interval prolongation)
Participation in another trial where an investigational drug has been administered within 60 days prior to planned administration of trial medication, or current participation in another trial involving administration of investigational drug
Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)
Inability to refrain from smoking on specified trial days
Alcohol abuse (consumption of more than 20 g per day)
Drug abuse or positive drug screening
Blood donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation during the trial
Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial
Inability to comply with dietary regimen of trial site
Subject is assessed as unsuitable for inclusion by the investigator, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study
In addition, the following trial-specific exclusion criteria apply:
History of relevant liver diseases such as disturbance of liver function, jaundice, drug induced liver injury, Dubin-Johnson syndrome, Rotor syndrome, or liver tumours
Thrombocytes below lower limit of normal or liver enzymes (Alanine transaminase (ALT), Aspartate transaminase (AST), Gamma-Glutamyl transpeptidase (GGT), Alkaline phosphatase (AP)) above upper limit of normal at the screening examination

Trial locations and contacts

1 site in 1 country.

Germany1 site

Humanpharmakologisches Zentrum Biberach
Biberach, 88397

Other trials in Germany

About this study

Official title: Effects of Rifampicin on the Pharmacokinetics of BI 425809 Following Oral Administration in Healthy Male Subjects (an Open-label, Two-period, Fixed-sequence Trial)

Conditions: Healthy
Being tested: Rifampicin, BI 425809

What participants receive

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

RifampicinDrug
once daily
BI 425809Drug
Also called Iclepertin
once daily

Study groups in NCT03082183
Study group	Role	What they receive
BI 425809 alone (reference, Treatment B) then BI 425809 + Rifampicin (test, Treatment A)	Experimental	BI 425809 alone (reference, Treatment B): Subjects were administered with a single dose of 25 mg BI 425809 orally in the morning after an overnight fast for a single day. BI 425809 + Rifampicin (test, Treatment A): Subjects were administered with multiple doses of 1 film coated tablet of Rifampicin (Eremfat®) 600 mg orally in the evening for 10 days and a single dose of 25 mg BI 425809 was administered on the seventh day of rifampicin (Eremfat®) treatment. The administrations of the single dose of BI 425809 in the first period and in the following combined treatment period were separated by a washout period of at least 49 days. Receives: Drug: Rifampicin; Drug: BI 425809

What is being measured

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

Area Under the Plasma Concentration-time Curve From 0 to 168 Hours Time Point of BI 425809 (AUC0-168).
This endpoint calculates area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 to 168 hour time point. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale including subject as random effect and treatment as fixed effect.
Measured: Pharmacokinetic samples were collected at 2:00 hour Pre-dose and at 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 3:30, 4:00, 4:30, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00, 72:00, 96:00 and 168:00 hours post dose.
Maximum Concentration of BI 425809 in Plasma (Cmax).
This outcome is maximum measured concentration of the BI 425809 in plasma.
Measured: Pharmacokinetic samples were collected at 2:00 hour Pre-dose and at 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 3:30, 4:00, 4:30, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00, 72:00, 96:00 and 168:00 hours post dose.

Secondary outcomes (2)

Area Under the Concentration-time Curve of BI 425809 in Plasma With and Without Co-administration of Rifampicin Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞).
This endpoint calculates area under the concentration-time curve of BI 425809 in plasma with and without adminstration of Rifampicin over the time interval from 0 extrapolated to infinity.
Measured: Pharmacokinetic samples were collected at 2:00 hour Pre-dose and at 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 3:30, 4:00, 4:30, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00, 72:00, 96:00 and 168:00 hours post dose.
Terminal Half-life of the Metabolite BI 761036 in Plasma (t1/2)
Half life is the period of time required for the concentration or amount of drug in the body to be reduced to exactly one-half of a given concentration or amount.
Measured: Pharmacokinetic samples were collected at 2:00 hour Pre-dose and at 3:00, 6:00, 12:00, 24:00, 34:00, 48:00, 72:00, 96:00, 168:00, 216:00, 264:00, 336:00, 408:00, 504:00, 576:00, 672:00, 744:00, 840:00 and 1008:00 hours post dose.

Timeline

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

28 Mar 201720 Jun 2017

First posted17 Mar 2017
Study start28 Mar 2017
Primary completion20 Jun 2017
Study completion20 Jun 2017

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: Single group
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03082183
Sponsor's protocol ID: 1346-0018
Other IDs: 2016-004862-24, 2016
Status last verified: Mar 2026
First submitted: 10 Mar 2017
Last updated: 30 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
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, Wunderlich G, Goettel M, Goetz S, Liesenfeld KH, Chan TS, Rosenbrock H, Sennewald R, Link J, Keller S, Wind S. Effects of Cytochrome P450 3A4 Induction and Inhibition on the Pharmacokinetics of BI 425809, a Novel Glycine Transporter 1 Inhibitor. Eur J Drug Metab Pharmacokinet. 2022 Jan;47(1):91-103. doi: 10.1007/s13318-021-00723-y. Epub 2021 Oct 29.
PubMed 34716565

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 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Rifampicin on the Pharmacokinetics of BI 425809 Following Oral Administration in Healthy Male Subjects (an Open-label, Two-period, Fixed-sequence Trial)
ClinicalTrials.gov ID: NCT03082183
Acronym / sponsor ID: 1346-0018
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 28 Mar 2017 (actual)
Primary completion: 20 Jun 2017 (actual)
Study completion: 20 Jun 2017 (actual)
First posted: 17 Mar 2017 (actual)
Results: Posted 30 Mar 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: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
BI 425809 alone (reference, Treatment B) then BI 425809 + Rifampicin (test, Treatment A)	Experimental	Drug: Rifampicin, Drug: BI 425809BI 425809 alone (reference, Treatment B): Subjects were administered with a single dose of 25 mg BI 425809 orally in the morning after an overnight fast for a single day. BI 425809 + Rifampicin (test, Treatment A): Subjects were administered with multiple doses of 1 film coated tablet of Rifampicin (Eremfat®) 600 mg orally in the evening for 10 days and a single dose of 25 mg BI 425809 was administered on the seventh day of rifampicin (Eremfat®) treatment. The administrations of the single dose of BI 425809 in the first period and in the following combined treatment period were separated by a washout period of at least 49 days.

Who may qualify

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

Key inclusion criteria (4 listed)

Healthy male subjects according to the assessment of the investigator, based on a complete medical history including a physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
Age of 18 to 55 years (incl.)
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

Key exclusion criteria (23 listed)

Any finding in the medical examination (including Blood Pressure (BP), Pulse 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
Rifampicinonce daily	Drug	BI 425809 alone (reference, Treatment B) then BI 425809 + Rifampicin (test, Treatment A)
BI 425809Also: Iclepertinonce daily	Drug	BI 425809 alone (reference, Treatment B) then BI 425809 + Rifampicin (test, Treatment A)

Primary outcome

Area Under the Plasma Concentration-time Curve From 0 to 168 Hours Time Point of BI 425809 (AUC0-168).
Time frame: Pharmacokinetic samples were collected at 2:00 hour Pre-dose and at 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 3:30, 4:00, 4:30, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00, 72:00, 96:00 and 168:00 hours post dose.
This endpoint calculates area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 to 168 hour time point. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale including subject as random effect and treatment as fixed effect.
Maximum Concentration of BI 425809 in Plasma (Cmax).
Time frame: Pharmacokinetic samples were collected at 2:00 hour Pre-dose and at 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 3:30, 4:00, 4:30, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00, 72:00, 96:00 and 168:00 hours post dose.
This outcome is maximum measured concentration of the BI 425809 in plasma.

2 secondary outcomes

Area Under the Concentration-time Curve of BI 425809 in Plasma With and Without Co-administration of Rifampicin Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞).
Time frame: Pharmacokinetic samples were collected at 2:00 hour Pre-dose and at 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 3:30, 4:00, 4:30, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00, 72:00, 96:00 and 168:00 hours post dose.
Terminal Half-life of the Metabolite BI 761036 in Plasma (t1/2)
Time frame: Pharmacokinetic samples were collected at 2:00 hour Pre-dose and at 3:00, 6:00, 12:00, 24:00, 34:00, 48:00, 72:00, 96:00, 168:00, 216:00, 264:00, 336:00, 408:00, 504:00, 576:00, 672:00, 744:00, 840:00 and 1008:00 hours post dose.

Results and safety

Results posted to the registry on 30 Mar 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
BI 425809 Alone (Reference, Treatment B) Then BI 425809 + Rifampicin (Test, Treatment A)	16	16

Primary outcome: Area Under the Plasma Concentration-time Curve From 0 to 168 Hours Time Point of BI 425809 (AUC0-168).

Time frame: Pharmacokinetic samples were collected at 2:00 hour Pre-dose and at 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 3:30, 4:00, 4:30, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00, 72:00, 96:00 and 168:00 hours post dose.. Geometric least squares mean (Standard Error). Unit: nanomole*hour/Litre (nmol*h/L)

Measure	BI 425809 n = 16	BI 425809 + Rifampicin (Eremfat®) n = 16
Value	8221.87 (na)	843.57 (na)

BI 425809 vs BI 425809 + Rifampicin (Eremfat®): Geometric mean ratio (%): 10.260 (90% CI 9.282 to 11.341)

Population analysed: Pharmacokinetic analysis set (PKS): All subjects from the treated set who provided at least 1 primary or secondary Pharmacokinetic (PK) endpoint value in any period that was judged as PK evaluable and was not affected by Protocol Violations (PV) relevant to the statistical evaluation of PK endpoints.

Primary outcome: Maximum Concentration of BI 425809 in Plasma (Cmax).

Measure	BI 425809 n = 16	BI 425809 + Rifampicin (Eremfat®) n = 16
Value	218.07 (na)	81.63 (na)

BI 425809 vs BI 425809 + Rifampicin (Eremfat®): Geometric mean ratio (%): 37.434 (90% CI 32.952 to 42.525)

Population analysed: Pharmacokinetic analysis set (PKS): All subjects from the treated set who provided at least 1 primary or secondary Pharmacokinetic (PK) endpoint value in any period that was judged as PK evaluable and was not affected by PVs relevant to the statistical evaluation of PK endpoints.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first drug administration until up to 11 days after last drug administration. All-cause mortality: Up to 23 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BI 425809	0 of 16 (0%)	2 of 16 (12.5%)	0 of 16
Loading Rifampicin (Eremfat®)	0 of 16 (0%)	16 of 16 (100%)	0 of 16
BI 425809 + Rifampicin (Eremfat®)	0 of 16 (0%)	3 of 16 (18.8%)	0 of 16

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34716565Desch M, Wunderlich G, Goettel M, Goetz S, Liesenfeld KH, Chan TS, Rosenbrock H, Sennewald R, Link J, Keller S, Wind S. Effects of Cytochrome P450 3A4 Induction and Inhibition on the Pharmacokinetics of BI 425809, a Novel Glycine Transporter 1 Inhibitor. Eur J Drug Metab Pharmacokinet. 2022 Jan;47(1):91-103. doi: 10.1007/s13318-021-00723-y. Epub 2021 Oct 29.
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.

The record lists no contact. Use the official record to reach the sponsor.

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 Rifampicin and BI 425809 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 4 inclusion and 23 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 30 Mar 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 30 Mar 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 Plasma Concentration-time Curve From 0 to 168 Hours Time Point of BI 425809 (AUC0-168). (time frame: Pharmacokinetic samples were collected at 2:00 hour Pre-dose and at 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 3:30, 4:00, 4:30, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00, 72:00, 96:00 and 168:00 hours post dose.). 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 NCT03082183, 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 30 Mar 2026.