HealthyPhase 1NCT02337283

Safety, Tolerability, and Pharmacokinetics of Multiple Rising Doses of BI 425809 Tablets for 12 Days to Young and Elderly Healthy Male and Female Volunteers and Comparison of Pharmacokinetics of a Single Oral Dose of BI 425809 (Morning Versus Evening)

A Phase 1 study testing 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.

Trial summary

The aim of the study is to investigate the safety, tolerability, and pharmacokinetics of multiple rising doses of BI 425809 tablets given orally once daily for 12 days to young and elderly healthy male and female volunteers and to compare single dose pharmacokinetics of BI 425809 given in the morning and in the… Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: BI 425809
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 96 participants
Where: 1 siteGermany
Study dates: 15 Jan 2015to 16 Nov 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 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male or female subjects according to the investigator´s assessment, 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 50 years (incl.) for young healthy volunteers or age of 65 to 80 years (incl.) for elderly healthy volunteers
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
Female subjects who meet any of the following criteria:
Surgically sterilised
Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous levels of follicle stimulating hormone (FSH) above 40 U/L and estradiol below 30 ng/L is confirmatory)

Who cannot join

Any finding in the medical examination (including BP, PR or 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 in young subjects, and systolic blood pressure greater than 150 mmHg, diastolic blood pressure greater than 95 mmHg in elderly subjects, 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
Surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication

Show all 10Show 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
Further exclusion criteria may apply

Trial locations and contacts

1 site in 1 country.

Germany1 site

CRS Clinical Research Services Mannheim GmbH
Mannheim, 68167

Other trials in Germany

About this study

Official title: Safety, Tolerability, and Pharmacokinetics of Multiple Rising Doses of BI 425809 Tablets Given Orally Once Daily for 12 Days to Young and Elderly Healthy Male and Female Volunteers (Randomised, Double-blind, Placebo-controlled Within Dose Groups Phase I Study)(Part 1) and Comparison of Pharmacokinetics of a Single Oral Dose of BI 425809 After Oral Administration in the Morning Versus Oral Administration in the Evening in Young Healthy Male and Female Volunteers (Randomised, Two-sequence, Open, Two Period, Two-way Cross Over) (Part 2)

Conditions: Healthy
Being tested: BI 425809, Placebo

What participants receive

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

BI 425809Drug
Also called Iclepertin
Tablets
PlaceboDrug
Tablets

Study groups in NCT02337283
Study group	Role	What they receive
BI 425809 very low dose - part I	Experimental	Part I only - very low dose tablet, oral administration with 240 ml water, over 14 days Receives: Drug: BI 425809
Placebo - part I	Placebo comparator	Part I only - placebo tablet, oral administration with 240ml water, over 14 days Receives: Drug: Placebo
BI 425809 low dose - part I	Experimental	Part I - low dose tablet, oral administration with 240 ml water, over 14 days Receives: Drug: BI 425809
BI 425809 medium dose - part I	Experimental	Part I only - medium dose tablet, oral administration with 240 ml water, over 14 days Receives: Drug: BI 425809
BI 425809 high dose -part I	Experimental	Part I only - high dose tablet, oral administration with 240 ml water, over 14 days Receives: Drug: BI 425809
BI 425809 low dose - part II	Experimental	Part II - one low dose tablet on day 1 of visit 2 and 2a
BI 425809 very high dose -part I	Experimental	Part I only - very high dose tablet, oral administration with 240 ml water, over 14 days Receives: Drug: BI 425809

What is being measured

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

Percentage of Subjects With Drug Related Adverse Events (AEs) in Part I
Percentage of subjects with drug related adverse events (AEs) in part I is reported
Measured: From first dose of study medication until 11 days after the last dose of study medication, up to 25 days
Area Under the Concentration-time Curve of the BI 425809 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) Part II
Area under the concentration-time curve of the BI 425809 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) part II is reported.
Measured: PK samples were taken at: 0, 0:30, 1, 2, 3, 3:30, 4, 4:30, 5, 6, 8, 10, 12, 24, 34, 48, 72, 96 hours after drug administration
Maximum Measured Concentration of the BI 425809 in Plasma (Cmax) Part II
Maximum measured concentration of the BI 425809 in plasma (Cmax) part II.
Measured: PK samples were taken at: 0, 0:30, 1, 2, 3, 3:30, 4, 4:30, 5, 6, 8, 10, 12, 24, 34, 48, 72, 96 hours after drug administration

Secondary outcomes (6)

Percentage of Subjects With Drug Related Adverse Events (AEs) in Part II
Percentage of subjects with drug related adverse events (AEs) in part II is reported.
Measured: From first dose of study medication until 11 days after the last dose of study medication, up to 12 days
Area Under the Concentration-time Curve of the BI 425809 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity) Part II
Area under the concentration-time curve of the BI 425809 in plasma over the time interval from 0 extrapolated to infinity (AUC 0-infinity) part II. After single dosing in the morning as well as in the evening.
Measured: PK samples were taken at: 0, 0:30, 1, 2, 3, 3:30, 4, 4:30, 5, 6, 8, 10, 12, 24, 34, 48, 72, 96 hours after drug administration
Area Under the Concentration-time Curve of the BI 425809 in Plasma Over the Time Interval From 0 to 24 Hours (AUC0-24) Part I
Area under the concentration-time curve of the BI 425809 in plasma over the time interval from 0 to 24 hours (AUC0-24) part I. After the first dose.
Measured: PK plasma samples were taken at: 2 hours before drug administration and 0:30, 1, 2, 3, 3:30, 4, 4:30, 5, 6, 8, 10, 12, 24 hours after the drug administration in YH and EH population
Area Under the Concentration-time Curve of the BI 425809 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss) Part I
The AUC of BI 425809 in plasma at steady state over a dosing interval (AUCτ,ss) in Part I was evaluated for all arms achieving steady state.
For the 75 mg twice-daily multiple-dose arm in young healthy subjects (YH), steady state was not achieved due to nonlinear pharmacokinetics; therefore, AUCτ,ss was not determined. Instead, AUCτ after the final dose (AUCτ,22) was calculated, representing AUC over one dosing interval (τ; dosing interval) after the last dose on Day 14 (22nd dose), not at steady state.
PK sampling:
75 mg BID YH: 2 h pre-dose and 0:30, 1-6 h (including 30-minute time points), 8, 10, 12, 24-240 h, 264, 288, 312-324 h (including 30-minute time points), 336, 360, 384, 408, 432, 456, 480, 504, 528 h post-dose.
Other arms: 0:30, 1-6 h (including 30-minute time points), 8, 10, 12, 24-240 h, 264-272 h (including 30-minute time points), 288, 360, 384, 408, 432, 456, 480, 504, and 528 h post-dose.
Time points 264-272 h apply only to 25 mg multiple-dose arms in YH and EH.
Measured: Up to 528 hours. The details are described in description.
Maximum Measured Concentration of the BI 425809 in Plasma (Cmax) Part I
Maximum measured concentration of the BI 425809 in plasma (Cmax) part I. After the first dose.
Measured: PK plasma samples were taken at: 0:30, 1, 2, 3, 3:30, 4, 4:30, 5, 6, 8, 10, 12, 24, 34, 48 and 58 hours after drug administration.
Maximum Measured Concentration of the BI 425809 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss) Part I
Maximum measured plasma concentration of BI 425809 at steady state over a dosing interval (Cmax,ss) in Part I was evaluated for all treatment arms achieving steady state
For the 75 mg twice-daily multiple-dose arm in young healthy subjects (YH), steady state was not achieved due to non-linear pharmacokinetics; therefore, Cmax,ss was not determined. Instead, Cmax after the final dose (Cmax,22) was calculated, representing the maximum observed concentration following the last dose on Day 14 (22nd dose), not at steady-state
PK sampling:
75 mg BID YH: 2 h pre-dose and 0:30, 1-6 h (including 30-min time points), 8, 10, 12, 24-240 h, 264, 288, 312-324 h (including 30-min time points), 336, 360, 384, 408, 432, 456, 480, 504, 528 h post-dose Other arms: 0:30, 1-6 h (including 30-min time points), 8, 10, 12, 24-240 h, 264-272 h (including 30-min time points); 288, 360, 384, 408, 432, 456, 480, 504, and 528 h post-dose
Time points 264-272 h apply only to 25 mg multiple-dose arms in YH and EH
Measured: Up to 528 hours. The details are described in description.

Timeline

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

15 Jan 201516 Nov 2015

First posted13 Jan 2015 (estimated)
Study start15 Jan 2015
Primary completion16 Nov 2015
Study completion16 Nov 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: Randomised
Intervention model: Single group
Masking: Double blind
Enrolment: 96 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02337283
Sponsor's protocol ID: 1346.2
Other IDs: 2014-004390-16, 2014
Status last verified: Apr 2026
First submitted: 9 Jan 2015
Last updated: 13 May 2026
Results posted: Yes, on ClinicalTrials.gov

Publications

Moschetti V, Schlecker C, Wind S, Goetz S, Schmitt H, Schultz A, Liesenfeld KH, Wunderlich G, Desch M. Multiple Rising Doses of Oral BI 425809, a GlyT1 Inhibitor, in Young and Elderly Healthy Volunteers: A Randomised, Double-Blind, Phase I Study Investigating Safety and Pharmacokinetics. Clin Drug Investig. 2018 Aug;38(8):737-750. doi: 10.1007/s40261-018-0660-2.
PubMed 29846887

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

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety, Tolerability, and Pharmacokinetics of Multiple Rising Doses of BI 425809 Tablets Given Orally Once Daily for 12 Days to Young and Elderly Healthy Male and Female Volunteers (Randomised, Double-blind, Placebo-controlled Within Dose Groups Phase I Study)(Part 1) and Comparison of Pharmacokinetics of a Single Oral Dose of BI 425809 After Oral Administration in the Morning Versus Oral Administration in the Evening in Young Healthy Male and Female Volunteers (Randomised, Two-sequence, Open, Two Period, Two-way Cross Over) (Part 2)
ClinicalTrials.gov ID: NCT02337283
Acronym / sponsor ID: 1346.2
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 96 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 15 Jan 2015 (actual)
Primary completion: 16 Nov 2015 (actual)
Study completion: 16 Nov 2015 (actual)
First posted: 13 Jan 2015 (estimated)
Results: Posted 13 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: Single group
Masking: Double blind
Number of arms: 7

Arm	Type	Receives
BI 425809 very low dose - part I	Experimental	Drug: BI 425809Part I only - very low dose tablet, oral administration with 240 ml water, over 14 days
Placebo - part I	Placebo comparator	Drug: PlaceboPart I only - placebo tablet, oral administration with 240ml water, over 14 days
BI 425809 low dose - part I	Experimental	Drug: BI 425809Part I - low dose tablet, oral administration with 240 ml water, over 14 days
BI 425809 medium dose - part I	Experimental	Drug: BI 425809Part I only - medium dose tablet, oral administration with 240 ml water, over 14 days
BI 425809 high dose -part I	Experimental	Drug: BI 425809Part I only - high dose tablet, oral administration with 240 ml water, over 14 days
BI 425809 low dose - part II	Experimental	–Part II - one low dose tablet on day 1 of visit 2 and 2a
BI 425809 very high dose -part I	Experimental	Drug: BI 425809Part I only - very high dose tablet, oral administration with 240 ml water, over 14 days

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Healthy male or female subjects according to the investigator´s assessment, 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 50 years (incl.) for young healthy volunteers or age of 65 to 80 years (incl.) for elderly healthy volunteers
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
Female subjects who meet any of the following criteria:

Key exclusion criteria (10 listed)

Any finding in the medical examination (including BP, PR or 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 in young subjects, and systolic blood pressure greater than 150 mmHg, diastolic blood pressure greater than 95 mmHg in elderly subjects, 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
BI 425809Also: IclepertinTablets	Drug	BI 425809 high dose -part I, BI 425809 low dose - part I, BI 425809 medium dose - part I, BI 425809 very high dose -part I, BI 425809 very low dose - part I
PlaceboTablets	Drug	Placebo - part I

Primary outcome

Percentage of Subjects With Drug Related Adverse Events (AEs) in Part I
Time frame: From first dose of study medication until 11 days after the last dose of study medication, up to 25 days
Percentage of subjects with drug related adverse events (AEs) in part I is reported
Area Under the Concentration-time Curve of the BI 425809 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) Part II
Time frame: PK samples were taken at: 0, 0:30, 1, 2, 3, 3:30, 4, 4:30, 5, 6, 8, 10, 12, 24, 34, 48, 72, 96 hours after drug administration
Area under the concentration-time curve of the BI 425809 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) part II is reported.
Maximum Measured Concentration of the BI 425809 in Plasma (Cmax) Part II
Time frame: PK samples were taken at: 0, 0:30, 1, 2, 3, 3:30, 4, 4:30, 5, 6, 8, 10, 12, 24, 34, 48, 72, 96 hours after drug administration
Maximum measured concentration of the BI 425809 in plasma (Cmax) part II.

6 secondary outcomes

Percentage of Subjects With Drug Related Adverse Events (AEs) in Part II
Time frame: From first dose of study medication until 11 days after the last dose of study medication, up to 12 days
Area Under the Concentration-time Curve of the BI 425809 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity) Part II
Time frame: PK samples were taken at: 0, 0:30, 1, 2, 3, 3:30, 4, 4:30, 5, 6, 8, 10, 12, 24, 34, 48, 72, 96 hours after drug administration
Area Under the Concentration-time Curve of the BI 425809 in Plasma Over the Time Interval From 0 to 24 Hours (AUC0-24) Part I
Time frame: PK plasma samples were taken at: 2 hours before drug administration and 0:30, 1, 2, 3, 3:30, 4, 4:30, 5, 6, 8, 10, 12, 24 hours after the drug administration in YH and EH population
Area Under the Concentration-time Curve of the BI 425809 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss) Part I
Time frame: Up to 528 hours. The details are described in description.
Maximum Measured Concentration of the BI 425809 in Plasma (Cmax) Part I
Time frame: PK plasma samples were taken at: 0:30, 1, 2, 3, 3:30, 4, 4:30, 5, 6, 8, 10, 12, 24, 34, 48 and 58 hours after drug administration.
Maximum Measured Concentration of the BI 425809 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss) Part I
Time frame: Up to 528 hours. The details are described in description.

Results and safety

Results posted to the registry on 13 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
Placebo - BI 425809- Young Healthy Subjects (YH)	15	14
Placebo - BI 425809- Elderly Healthy Subjects (EH)	6	6
BI 425809 - 10 Milligram (mg) Multiple Dose in YH	9	9
BI 425809 - 25 mg Multiple Dose in YH	9	9
BI 425809 - 25 mg Multiple Dose in EH	9	9
BI 425809 - 50 mg Multiple Dose in YH	9	9
BI 425809 - 50 mg Multiple Dose in EH	9	8
BI 425809 - 75 mg Once Daily Multiple Dose in YH	9	9
BI 425809 - 75 mg Twice Daily Multiple Dose in YH	9	9
BI 425809 - 25 mg Single Dose Morning (R) / Evening (T) in YH	6	5
BI 425809 - 25 mg Single Dose Evening (T) / Morning (R) in YH	6	6

Primary outcome: Percentage of Subjects With Drug Related Adverse Events (AEs) in Part I

Time frame: From first dose of study medication until 11 days after the last dose of study medication, up to 25 days. Number. Unit: Percentage of participants

Measure	Placebo - BI 425809- Young Healthy Subjects (YH) n = 15	Placebo - BI 425809- Elderly Healthy Subjects (EH) n = 6	BI 425809 - 10 Milligram (mg) Multiple Dose in YH n = 9	BI 425809 - 25 mg Multiple Dose in YH n = 9	BI 425809 - 25 mg Multiple Dose in EH n = 9	BI 425809 - 50 mg Multiple Dose in YH n = 9	BI 425809 - 50 mg Multiple Dose in EH n = 9	BI 425809 - 75 mg Once Daily Multiple Dose in YH n = 9	BI 425809 - 75 mg Twice Daily Multiple Dose in YH n = 9
Value	46.7	50.0	44.4	66.7	66.7	66.7	88.9	55.6	66.7

Population analysed: The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.

Primary outcome: Area Under the Concentration-time Curve of the BI 425809 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) Part II

Time frame: PK samples were taken at: 0, 0:30, 1, 2, 3, 3:30, 4, 4:30, 5, 6, 8, 10, 12, 24, 34, 48, 72, 96 hours after drug administration. Geometric mean (Geometric Coefficient of Variation). Unit: nanomol (nmol)* hours (h) / Litre (L)

Measure	BI 425809 - 25 mg Single Dose Morning (R) in YH n = 12	BI 425809 - 25 mg Single Dose Evening (T) in YH n = 11
Value	7000 (32.7)	8480 (19.5)

BI 425809 - 25 mg Single Dose Morning (R) in YH vs BI 425809 - 25 mg Single Dose Evening (T) in YH: Ratio of adjusted geometric means (%): 120.13 (90% CI 107.23 to 134.58)

Population analysed: Pharmacokinetic evening set (PKS-E): set included all subjects from the TS who participated in part 2 of the trial and provided at least 1 primary Pharmacokinetic (PK) endpoint value that was judged as PK evaluable and was not affected by protocol violations relevant to the bioavailability evaluation of PK endpoints.

Primary outcome: Maximum Measured Concentration of the BI 425809 in Plasma (Cmax) Part II

Measure	BI 425809 - 25 mg Single Dose Morning (R) in YH n = 12	BI 425809 - 25 mg Single Dose Evening (T) in YH n = 11
Value	241 (37.1)	277 (19.8)

BI 425809 - 25 mg Single Dose Morning (R) in YH vs BI 425809 - 25 mg Single Dose Evening (T) in YH: Ratio of adjusted geometric means (%): 115.33 (90% CI 98.073 to 135.631)

Population analysed: Pharmacokinetic evening set (PKS-E): set included all subjects from the TS who participated in part 2 of the trial and provided at least 1 primary PK endpoint value that was judged as PK evaluable and was not affected by protocol violations relevant to the bioavailability evaluation of PK endpoints.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo - BI 425809- Young Healthy Subjects (YH)	0 of 15 (0%)	8 of 15 (53.3%)	0 of 15
Placebo - BI 425809- Elderly Healthy Subjects (EH)	0 of 6 (0%)	3 of 6 (50%)	0 of 6
BI 425809 - 10 Milligram (mg) Multiple Dose in YH	0 of 9 (0%)	5 of 9 (55.6%)	0 of 9
BI 425809 - 25 mg Multiple Dose in YH	0 of 9 (0%)	7 of 9 (77.8%)	0 of 9
BI 425809 - 25 mg Multiple Dose in EH	0 of 9 (0%)	8 of 9 (88.9%)	0 of 9
BI 425809 - 50 mg Multiple Dose in YH	0 of 9 (0%)	6 of 9 (66.7%)	0 of 9
BI 425809 - 50 mg Multiple Dose in EH	0 of 9 (0%)	8 of 9 (88.9%)	0 of 9
BI 425809 - 75 mg Once Daily Multiple Dose in YH	0 of 9 (0%)	6 of 9 (66.7%)	0 of 9
BI 425809 - 75 mg Twice Daily Multiple Dose in YH	0 of 9 (0%)	6 of 9 (66.7%)	0 of 9
BI 425809 - 25 mg Single Dose Morning (R) in YH	0 of 12 (0%)	2 of 12 (16.7%)	0 of 12
BI 425809 - 25 mg Single Dose Evening (T) in YH	0 of 11 (0%)	0 of 11 (0%)	0 of 11

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29846887Moschetti V, Schlecker C, Wind S, Goetz S, Schmitt H, Schultz A, Liesenfeld KH, Wunderlich G, Desch M. Multiple Rising Doses of Oral BI 425809, a GlyT1 Inhibitor, in Young and Elderly Healthy Volunteers: A Randomised, Double-Blind, Phase I Study Investigating Safety and Pharmacokinetics. Clin Drug Investig. 2018 Aug;38(8):737-750. doi: 10.1007/s40261-018-0660-2.
Related InfoLink provided by the sponsor.

Related trials for Healthy

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

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 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 7 inclusion and 10 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 13 May 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 13 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?

Percentage of Subjects With Drug Related Adverse Events (AEs) in Part I (time frame: From first dose of study medication until 11 days after the last dose of study medication, up to 25 days). The study lists 3 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 NCT02337283, 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 13 May 2026.