HealthyPhase 1NCT02068690

Safety, Tolerability, and Pharmacokinetics of Single Doses BI 425809

A Phase 1 study testing BI 425809 PfOS and BI 425809 tablet 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 investigate safety, tolerability, and pharmacokinetics of BI 425809 following single rising doses of BI 425809 in healthy male volunteers; To explore dose proportionality of BI 425809 as oral drinking solution; To investigate relative bioavailability of BI 425809 oral drinking solution fasted compared to BI 425809… Read more about this study

Who is it for?: Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: BI 425809 PfOS and BI 425809 tablet
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 83 participants
Where: 1 siteGermany
Study dates: 20 Mar 2014to 10 Sep 2014
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 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male subjects
Age 18 to 45 years (incl.)
Body mass index (BMI) 18.5 to 29.9 kg/m2 (incl.)
Subject must be able to understand and comply with study requirements

Who cannot join

Any finding in the medical examination (including blood pressure (BP), pulse rate (PR) or electrocardiogram (ECG)) deviating from normal and judged clinically relevant by the investigator
Repeated measurement of systolic blood pressure <90 or >140 mmHg, or diastolic blood pressure <50 or >90 mmHg, or pulse rate <50 or >90
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
Any evidence of a concomitant disease judged clinically relevant by the investigator
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug(s)
Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders

Trial locations and contacts

1 site in 1 country.

Germany1 site

1346.1.1 Boehringer Ingelheim Investigational Site
Ingelheim

Other trials in Germany

About this study

Official title: Safety, Tolerability, and Pharmacokinetics of Single Rising Oral Doses of BI 425809 in Healthy Male Subjects (Partially Randomised, Single-blind, Placebo-controlled) and Investigation of Relative Bioavailability and Food Effect of BI 425809 (Open-label, Randomised, Three-way Crossover)

Conditions: Healthy
Being tested: BI 425809 PfOS, Placebo PfOS, BI 425809 tablet

What participants receive

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

BI 425809 PfOSDrug
Also called Iclepertin
BI 425809 as a powder for an oral solution (PfOS)
Placebo PfOSDrug
Placebo as a powder for an oral solution (PfOS)
BI 425809 tabletDrug
Also called Iclepertin
BI 425809 as a tablet

Study groups in NCT02068690
Study group	Role	What they receive
SRD Part: Placebo	Placebo comparator	Participants received a single dose of oral solution of placebo matching BI 425809. SRD = Single Rising Dose. Receives: Drug: Placebo PfOS
SRD Part: 0.5 mg BI 425809	Experimental	Participants received a single dose of oral solution containing 0.5 milligrams (mg) of BI 425809. SRD = Single Rising Dose. Receives: Drug: BI 425809 PfOS
SRD Part: 1 mg BI 425809	Experimental	Participants received a single dose of oral solution containing 1 milligram (mg) of BI 425809. SRD = Single Rising Dose. Receives: Drug: BI 425809 PfOS
SRD Part: 2 mg BI 425809	Experimental	Participants received a single dose of oral solution containing 2 milligrams (mg) of BI 425809. SRD = Single Rising Dose. Receives: Drug: BI 425809 PfOS
SRD Part: 5 mg BI 425809	Experimental	Participants received a single dose of oral solution containing 5 milligrams (mg) of BI 425809. SRD = Single Rising Dose. Receives: Drug: BI 425809 PfOS
SRD Part: 10 mg BI425809	Experimental	Participants received a single dose of oral solution containing 10 milligrams (mg) of BI 425809. SRD = Single Rising Dose. Receives: Drug: BI 425809 PfOS
SRD Part: 25 mg BI 425809	Experimental	Participants received a single dose of oral solution containing 25 milligrams (mg) of BI 425809. SRD = Single Rising Dose. Receives: Drug: BI 425809 PfOS
SRD Part: 50 mg BI 425809	Experimental	Participants received a single dose of oral solution containing 50 milligrams (mg) of BI 425809. SRD = Single Rising Dose. Receives: Drug: BI 425809 PfOS
SRD Part: 100 mg BI 425809	Experimental	Participants received a single dose of oral solution containing 100 milligrams (mg) of BI 425809. SRD = Single Rising Dose. Receives: Drug: BI 425809 PfOS
SRD Part: 150 mg BI 425809	Experimental	Participants received a single dose of oral solution containing 150 milligrams (mg) of BI 425809. SRD = Single Rising Dose. Receives: Drug: BI 425809 PfOS
BA/FE Part: 25 mg BI 425809, R/T1/T2	Experimental	Participants were administered 25 mg of BI 425809 as a tablet without food (reference treatment R), 25 mg of BI 425809 as a tablet after a standardized high-fat, high-calorie meal (test treatment T1), and 25 mg of BI 425809 as a powder in an oral solution without food (test treatment T2). The 3 treatments were separated by a washout period of at least 14 days. BA = Bioavailability, FE = Food Effect. Receives: Drug: BI 425809 PfOS; Drug: BI 425809 tablet
BA/FE Part: 25 mg BI 425809, R/T2/T1	Experimental	Participants were administered 25 mg of BI 425809 as a tablet without food (reference treatment R), 25 mg of BI 425809 as a powder in an oral solution without food (test treatment T2), and 25 mg of BI 425809 as a tablet after a standardized high-fat, high-calorie meal (test treatment T1). The 3 treatments were separated by a washout period of at least 14 days. BA = Bioavailability, FE = Food Effect. Receives: Drug: BI 425809 PfOS; Drug: BI 425809 tablet
BA/FE Part: 25 mg BI 425809, T1/T2/R	Experimental	Participants were administered 25 mg of BI 425809 as a tablet after a standardized high-fat, high-calorie meal (test treatment T1), 25 mg of BI 425809 as a powder in an oral solution without food (test treatment T2), and 25 mg of BI 425809 as a tablet without food (reference treatment R). The 3 treatments were separated by a washout period of at least 14 days. BA = Bioavailability, FE = Food Effect. Receives: Drug: BI 425809 PfOS; Drug: BI 425809 tablet
BA/FE Part: 25 mg BI 425809, T1/R/T2	Experimental	Participants were administered 25 mg of BI 425809 as a tablet after a standardized high-fat, high-calorie meal (test treatment T1), 25 mg of BI 425809 as a tablet without food (reference treatment R), and 25 mg of BI 425809 as a powder in an oral solution without food (test treatment T2). The 3 treatments were separated by a washout period of at least 14 days. BA = Bioavailability, FE = Food Effect. Receives: Drug: BI 425809 PfOS; Drug: BI 425809 tablet
BA/FE Part: 25 mg BI 425809, T2/T1/R	Experimental	Participants were administered 25 mg of BI 425809 as a powder in an oral solution without food (test treatment T2), 25 mg of BI 425809 as a tablet after a standardized high-fat, high-calorie meal (test treatment T1), and 25 mg of BI 425809 as a tablet without food (reference treatment R). The 3 treatments were separated by a washout period of at least 14 days. BA = Bioavailability, FE = Food Effect. Receives: Drug: BI 425809 PfOS; Drug: BI 425809 tablet
BA/FE Part: 25 mg BI 425809, T2/R/T1	Experimental	Participants were administered 25 mg of BI 425809 as a powder in an oral solution without food (test treatment T2), 25 mg of BI 425809 as a tablet without food (reference treatment R), and 25 mg of BI 425809 as a tablet after a standardized high-fat, high-calorie meal (test treatment T1). The 3 treatments were separated by a washout period of at least 14 days. BA = Bioavailability, FE = Food Effect. Receives: Drug: BI 425809 PfOS; Drug: BI 425809 tablet

What is being measured

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

Number of Participants With Drug-related Adverse Events (AE)
Number of participants with drug-related Adverse Events (AE). Drug-relatedness was assessed by the investigator.
Measured: SRD Part: From the time of first drug administration until the end of study, up to 18 days. BA/FE Part: From the time of first drug administration until the end of the intervention period, up to 18 days for each intervention.

Secondary outcomes (4)

SRD Part: Maximum Concentration of BI 425809 in Plasma (Cmax)
Maximum measured concentration of BI 425809 in plasma (Cmax) in the Single Rising Dose (SRD) part of the trial is reported.
Measured: 2 hours (h) before drug administration and 15 minutes (m), 30m, 45m, 1h, 1h30m, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h, 120h, 144h, 168h, 192h after drug administration.
BA/FE Part: Maximum Concentration of BI 425809 in Plasma (Cmax)
Maximum measured concentration of BI 425809 in plasma (Cmax) in the bioavailability/food effect (BA/FE) part of the trial is reported.
Measured: 2 hours (h) before drug administration and 15 minutes (m), 30m, 45m, 1h, 1h30m, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h, 120h, 144h, 168h, 192h after drug administration.
SRD Part: Area Under the Concentration-time Curve of BI 425809 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC(0-∞))
Area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 extrapolated to infinity (AUC(0-∞)) in the Single Rising Dose (SRD) part of the trial is reported.
Measured: 2 hours (h) before drug administration and 15 minutes (m), 30m, 45m, 1h, 1h30m, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h, 120h, 144h, 168h, 192h after drug administration.
BA/FE Part: Area Under the Concentration-time Curve of BI 425809 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC(0-∞))
Area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 extrapolated to infinity (AUC(0-∞)) in the Bioavailability/Food Effect (BA/FE) part of the trial is reported.
Measured: 2 hours (h) before drug administration and 15 minutes (m), 30m, 45m, 1h, 1h30m, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h, 120h, 144h, 168h, 192h after drug administration.

Timeline

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

20 Mar 201410 Sep 2014

First posted21 Feb 2014 (estimated)
Study start20 Mar 2014
Primary completion10 Sep 2014
Study completion10 Sep 2014

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: Randomised
Intervention model: Crossover
Model description: Part 1 of this study was conducted as a sequential assignment, while Part 2 of this study was conducted as a crossover assignment.
Masking: None (open label)
Enrolment: 83 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02068690
Sponsor's protocol ID: 1346.1
Other IDs: 2013-004937-34
Status last verified: May 2026
First submitted: 20 Feb 2014
Last updated: 3 Jun 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

Moschetti V, Desch M, Goetz S, Liesenfeld KH, Rosenbrock H, Kammerer KP, Wunderlich G, Wind S. Safety, Tolerability and Pharmacokinetics of Oral BI 425809, a Glycine Transporter 1 Inhibitor, in Healthy Male Volunteers: A Partially Randomised, Single-Blind, Placebo-Controlled, First-in-Human Study. Eur J Drug Metab Pharmacokinet. 2018 Apr;43(2):239-249. doi: 10.1007/s13318-017-0440-z.
PubMed 29076028

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 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety, Tolerability, and Pharmacokinetics of Single Rising Oral Doses of BI 425809 in Healthy Male Subjects (Partially Randomised, Single-blind, Placebo-controlled) and Investigation of Relative Bioavailability and Food Effect of BI 425809 (Open-label, Randomised, Three-way Crossover)
ClinicalTrials.gov ID: NCT02068690
Acronym / sponsor ID: 1346.1
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 83 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 20 Mar 2014 (actual)
Primary completion: 10 Sep 2014 (actual)
Study completion: 10 Sep 2014 (actual)
First posted: 21 Feb 2014 (estimated)
Results: Posted 5 May 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: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 16
Model description: Part 1 of this study was conducted as a sequential assignment, while Part 2 of this study was conducted as a crossover assignment.

Arm	Type	Receives
SRD Part: Placebo	Placebo comparator	Drug: Placebo PfOSParticipants received a single dose of oral solution of placebo matching BI 425809. SRD = Single Rising Dose.
SRD Part: 0.5 mg BI 425809	Experimental	Drug: BI 425809 PfOSParticipants received a single dose of oral solution containing 0.5 milligrams (mg) of BI 425809. SRD = Single Rising Dose.
SRD Part: 1 mg BI 425809	Experimental	Drug: BI 425809 PfOSParticipants received a single dose of oral solution containing 1 milligram (mg) of BI 425809. SRD = Single Rising Dose.
SRD Part: 2 mg BI 425809	Experimental	Drug: BI 425809 PfOSParticipants received a single dose of oral solution containing 2 milligrams (mg) of BI 425809. SRD = Single Rising Dose.
SRD Part: 5 mg BI 425809	Experimental	Drug: BI 425809 PfOSParticipants received a single dose of oral solution containing 5 milligrams (mg) of BI 425809. SRD = Single Rising Dose.
SRD Part: 10 mg BI425809	Experimental	Drug: BI 425809 PfOSParticipants received a single dose of oral solution containing 10 milligrams (mg) of BI 425809. SRD = Single Rising Dose.
SRD Part: 25 mg BI 425809	Experimental	Drug: BI 425809 PfOSParticipants received a single dose of oral solution containing 25 milligrams (mg) of BI 425809. SRD = Single Rising Dose.
SRD Part: 50 mg BI 425809	Experimental	Drug: BI 425809 PfOSParticipants received a single dose of oral solution containing 50 milligrams (mg) of BI 425809. SRD = Single Rising Dose.
SRD Part: 100 mg BI 425809	Experimental	Drug: BI 425809 PfOSParticipants received a single dose of oral solution containing 100 milligrams (mg) of BI 425809. SRD = Single Rising Dose.
SRD Part: 150 mg BI 425809	Experimental	Drug: BI 425809 PfOSParticipants received a single dose of oral solution containing 150 milligrams (mg) of BI 425809. SRD = Single Rising Dose.
BA/FE Part: 25 mg BI 425809, R/T1/T2	Experimental	Drug: BI 425809 PfOS, Drug: BI 425809 tabletParticipants were administered 25 mg of BI 425809 as a tablet without food (reference treatment R), 25 mg of BI 425809 as a tablet after a standardized high-fat, high-calorie meal (test treatment T1), and 25 mg of BI 425809 as a powder in an oral solution without food (test treatment T2). The 3 treatments were separated by a washout period of at least 14 days. BA = Bioavailability, FE = Food Effect.
BA/FE Part: 25 mg BI 425809, R/T2/T1	Experimental	Drug: BI 425809 PfOS, Drug: BI 425809 tabletParticipants were administered 25 mg of BI 425809 as a tablet without food (reference treatment R), 25 mg of BI 425809 as a powder in an oral solution without food (test treatment T2), and 25 mg of BI 425809 as a tablet after a standardized high-fat, high-calorie meal (test treatment T1). The 3 treatments were separated by a washout period of at least 14 days. BA = Bioavailability, FE = Food Effect.
BA/FE Part: 25 mg BI 425809, T1/T2/R	Experimental	Drug: BI 425809 PfOS, Drug: BI 425809 tabletParticipants were administered 25 mg of BI 425809 as a tablet after a standardized high-fat, high-calorie meal (test treatment T1), 25 mg of BI 425809 as a powder in an oral solution without food (test treatment T2), and 25 mg of BI 425809 as a tablet without food (reference treatment R). The 3 treatments were separated by a washout period of at least 14 days. BA = Bioavailability, FE = Food Effect.
BA/FE Part: 25 mg BI 425809, T1/R/T2	Experimental	Drug: BI 425809 PfOS, Drug: BI 425809 tabletParticipants were administered 25 mg of BI 425809 as a tablet after a standardized high-fat, high-calorie meal (test treatment T1), 25 mg of BI 425809 as a tablet without food (reference treatment R), and 25 mg of BI 425809 as a powder in an oral solution without food (test treatment T2). The 3 treatments were separated by a washout period of at least 14 days. BA = Bioavailability, FE = Food Effect.
BA/FE Part: 25 mg BI 425809, T2/T1/R	Experimental	Drug: BI 425809 PfOS, Drug: BI 425809 tabletParticipants were administered 25 mg of BI 425809 as a powder in an oral solution without food (test treatment T2), 25 mg of BI 425809 as a tablet after a standardized high-fat, high-calorie meal (test treatment T1), and 25 mg of BI 425809 as a tablet without food (reference treatment R). The 3 treatments were separated by a washout period of at least 14 days. BA = Bioavailability, FE = Food Effect.
BA/FE Part: 25 mg BI 425809, T2/R/T1	Experimental	Drug: BI 425809 PfOS, Drug: BI 425809 tabletParticipants were administered 25 mg of BI 425809 as a powder in an oral solution without food (test treatment T2), 25 mg of BI 425809 as a tablet without food (reference treatment R), and 25 mg of BI 425809 as a tablet after a standardized high-fat, high-calorie meal (test treatment T1). The 3 treatments were separated by a washout period of at least 14 days. BA = Bioavailability, FE = Food Effect.

Who may qualify

Ages: 18 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Healthy male subjects
Age 18 to 45 years (incl.)
Body mass index (BMI) 18.5 to 29.9 kg/m2 (incl.)
Subject must be able to understand and comply with study requirements

Key exclusion criteria (7 listed)

Any finding in the medical examination (including blood pressure (BP), pulse rate (PR) or electrocardiogram (ECG)) deviating from normal and judged clinically relevant by the investigator
Repeated measurement of systolic blood pressure <90 or >140 mmHg, or diastolic blood pressure <50 or >90 mmHg, or pulse rate <50 or >90
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
Any evidence of a concomitant disease judged 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
BI 425809 PfOSAlso: IclepertinBI 425809 as a powder for an oral solution (PfOS)	Drug	BA/FE Part: 25 mg BI 425809, R/T1/T2, BA/FE Part: 25 mg BI 425809, R/T2/T1, BA/FE Part: 25 mg BI 425809, T1/R/T2, BA/FE Part: 25 mg BI 425809, T1/T2/R, BA/FE Part: 25 mg BI 425809, T2/R/T1, BA/FE Part: 25 mg BI 425809, T2/T1/R, SRD Part: 0.5 mg BI 425809, SRD Part: 1 mg BI 425809, SRD Part: 10 mg BI425809, SRD Part: 100 mg BI 425809, SRD Part: 150 mg BI 425809, SRD Part: 2 mg BI 425809, SRD Part: 25 mg BI 425809, SRD Part: 5 mg BI 425809, SRD Part: 50 mg BI 425809
Placebo PfOSPlacebo as a powder for an oral solution (PfOS)	Drug	SRD Part: Placebo
BI 425809 tabletAlso: IclepertinBI 425809 as a tablet	Drug	BA/FE Part: 25 mg BI 425809, R/T1/T2, BA/FE Part: 25 mg BI 425809, R/T2/T1, BA/FE Part: 25 mg BI 425809, T1/R/T2, BA/FE Part: 25 mg BI 425809, T1/T2/R, BA/FE Part: 25 mg BI 425809, T2/R/T1, BA/FE Part: 25 mg BI 425809, T2/T1/R

Primary outcome

Number of Participants With Drug-related Adverse Events (AE)
Time frame: SRD Part: From the time of first drug administration until the end of study, up to 18 days. BA/FE Part: From the time of first drug administration until the end of the intervention period, up to 18 days for each intervention.
Number of participants with drug-related Adverse Events (AE). Drug-relatedness was assessed by the investigator.

4 secondary outcomes

SRD Part: Maximum Concentration of BI 425809 in Plasma (Cmax)
Time frame: 2 hours (h) before drug administration and 15 minutes (m), 30m, 45m, 1h, 1h30m, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h, 120h, 144h, 168h, 192h after drug administration.
BA/FE Part: Maximum Concentration of BI 425809 in Plasma (Cmax)
Time frame: 2 hours (h) before drug administration and 15 minutes (m), 30m, 45m, 1h, 1h30m, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h, 120h, 144h, 168h, 192h after drug administration.
SRD Part: Area Under the Concentration-time Curve of BI 425809 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC(0-∞))
Time frame: 2 hours (h) before drug administration and 15 minutes (m), 30m, 45m, 1h, 1h30m, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h, 120h, 144h, 168h, 192h after drug administration.
BA/FE Part: Area Under the Concentration-time Curve of BI 425809 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC(0-∞))
Time frame: 2 hours (h) before drug administration and 15 minutes (m), 30m, 45m, 1h, 1h30m, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h, 120h, 144h, 168h, 192h after drug administration.

Results and safety

Results posted to the registry on 5 May 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
SRD Part: Placebo	18	18
SRD Part: 0.5 mg BI 425809	6	6
SRD Part: 1 mg BI 425809	6	6
SRD Part: 2 mg BI 425809	6	6
SRD Part: 5 mg BI 425809	6	6
SRD Part: 10 mg BI425809	6	6
SRD Part: 25 mg BI 425809	6	6
SRD Part: 50 mg BI 425809	6	6
SRD Part: 100 mg BI 425809	6	6
SRD Part: 150 mg BI 425809	6	6
BA/FE Part: 25 mg BI 425809, R/T1/T2	2	2
BA/FE Part: 25 mg BI 425809, R/T2/T1	2	2
BA/FE Part: 25 mg BI 425809, T1/T2/R	2	2
BA/FE Part: 25 mg BI 425809, T1/R/T2	2	2
BA/FE Part: 25 mg BI 425809, T2/T1/R	2	2
BA/FE Part: 25 mg BI 425809, T2/R/T1	1	1

Primary outcome: Number of Participants With Drug-related Adverse Events (AE)

Time frame: SRD Part: From the time of first drug administration until the end of study, up to 18 days. BA/FE Part: From the time of first drug administration until the end of the intervention period, up to 18 days for each intervention.. Count of participants. Unit: Participants

Measure	SRD Part: Placebo n = 18	SRD Part: 0.5 mg BI 425809 n = 6	SRD Part: 1 mg BI 425809 n = 6	SRD Part: 2 mg BI 425809 n = 6	SRD Part: 5 mg BI 425809 n = 6	SRD Part: 10 mg BI425809 n = 6	SRD Part: 25 mg BI 425809 n = 6	SRD Part: 50 mg BI 425809 n = 6	SRD Part: 100 mg BI 425809 n = 6	SRD Part: 150 mg BI 425809 n = 6	BA/FE Part: Tablet Without Food n = 11	BA/FE Part: Tablet With Food n = 11	BA/FE Part: Oral Solution Without Food n = 11
Value	3	1	2	1	2	1	3	4	4	6	3	1	4

Population analysed: Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.

4 secondary outcomes are reported in the full results.

Adverse events

Group	Serious adverse events	Other adverse events	Deaths
SRD Part: Placebo	0 of 18 (0%)	5 of 18 (27.8%)	Not reported
SRD Part: 0.5 mg BI 425809	0 of 6 (0%)	1 of 6 (16.7%)	Not reported
SRD Part: 1 mg BI 425809	0 of 6 (0%)	2 of 6 (33.3%)	Not reported
SRD Part: 2 mg BI 425809	0 of 6 (0%)	3 of 6 (50%)	Not reported
SRD Part: 5 mg BI 425809	0 of 6 (0%)	5 of 6 (83.3%)	Not reported
SRD Part: 10 mg BI425809	0 of 6 (0%)	3 of 6 (50%)	Not reported
SRD Part: 25 mg BI 425809	0 of 6 (0%)	5 of 6 (83.3%)	Not reported
SRD Part: 50 mg BI 425809	0 of 6 (0%)	5 of 6 (83.3%)	Not reported
SRD Part: 100 mg BI 425809	0 of 6 (0%)	4 of 6 (66.7%)	Not reported
SRD Part: 150 mg BI 425809	0 of 6 (0%)	6 of 6 (100%)	Not reported
BA/FE Part: Tablet Without Food	0 of 11 (0%)	4 of 11 (36.4%)	Not reported
BA/FE Part: Tablet With Food	0 of 11 (0%)	1 of 11 (9.1%)	Not reported
BA/FE Part: Oral Solution Without Food	0 of 11 (0%)	6 of 11 (54.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29076028Moschetti V, Desch M, Goetz S, Liesenfeld KH, Rosenbrock H, Kammerer KP, Wunderlich G, Wind S. Safety, Tolerability and Pharmacokinetics of Oral BI 425809, a Glycine Transporter 1 Inhibitor, in Healthy Male Volunteers: A Partially Randomised, Single-Blind, Placebo-Controlled, First-in-Human Study. Eur J Drug Metab Pharmacokinet. 2018 Apr;43(2):239-249. doi: 10.1007/s13318-017-0440-z.
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 BI 425809 PfOS and BI 425809 tablet 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 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 3 Jun 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. Some participants in this study may receive a placebo. 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 5 May 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?

Number of Participants With Drug-related Adverse Events (AE) (time frame: SRD Part: From the time of first drug administration until the end of study, up to 18 days. BA/FE Part: From the time of first drug administration until the end of the intervention period, up to 18 days for each intervention.). 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 NCT02068690, 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 3 Jun 2026.