HealthyPhase 1NCT03210272

This Study in Healthy Men Tests How Different Doses of BI 1358894 Are Taken up in the Body and How Well They Are Tolerated. The Study Also Looks at How Food Influences the Amount of BI 1358894 in the Blood

A Phase 1 study testing BI 1358894, BI 1358894 (Test) and BI 1358894 (Reference) 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 safety and tolerability of BI 1358894 in healthy male subjects following oral administration of single rising doses. Secondary objectives are the exploration of the pharmacokinetics (PK), including dose proportionality of BI 1358894 after single dosing. 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 1358894, BI 1358894 (Test) and BI 1358894 (Reference)
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: 18 Jul 2017to 18 Feb 2019
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 according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
Age of 18 to 45 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 GCP and local legislation
Willingness to comply with contraception requirements. Subjects who are sexually active, must use, with their female partner, adequate contraception throughout the study and until one month after the last administration of trial medication. Adequate methods are:
Sexual abstinence or

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A vasectomy performed at least 1 year prior to screening in combination with a barrier method (condom) or
Surgical sterilisation (including bilateral tubal occlusion, hysterectomy or bilateral oophorectomy) of the subjects female partner or
The use of condoms, if the female partner uses in addition an adequate contraception method, e.g., intrauterine device (IUD), hormonal contraception (e.g. implants, injectables, combined oral or vaginal contraceptives) that started at least 2 months prior to first drug administration, or barrier method (e.g. diaphragm with spermicide)
Unprotected sexual intercourse with a pregnant female partner is not allowed throughout the study and until one month after the last administration of trial medication

Who cannot join

Any finding in the medical examination (including BP, PR or ECG) is deviating from normal
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
C-Reactive Protein > ULN, erythrocyte sedimentation rate (ESR) ≥ 15 millimeters/hour, liver and kidney parameter above ULN, other laboratory values outside the reference range 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)

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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 30 g per day for males)
Drug abuse as per investigator judgment 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
A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 450 ms in males) or any other relevant ECG finding at screening
A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome)
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
Any lifetime history of suicidal behaviour (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behaviour)
Any suicidal ideation of type 2 to 5 on the C-SSRS in the past 12 months (i.e. active suicidal thought, active suicidal thought with method, active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent)

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 Single Rising Oral Doses of BI 1358894 in Healthy Male Subjects (Single-blind, Partially Randomised, Placebo-controlled Parallel Group Design) and Effect of Food on the Relative Bioavailability of BI 1358894 (Open-label, Randomised, Two-way Cross-over)

Conditions: Healthy
Being tested: Placebo, BI 1358894, BI 1358894 (Test), BI 1358894 (Reference)

What participants receive

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

PlaceboDrug
Tablet
BI 1358894Drug
Tablet
BI 1358894 (Test)Drug
Fasting state
BI 1358894 (Reference)Drug
Fed state

Study groups in NCT03210272
Study group	Role	What they receive
Single rising dose part	Experimental	Group of healthy male volunteers receive rising single doses of BI 1358894 Receives: Drug: Placebo; Drug: BI 1358894
Food effect part	Experimental	Group of healthy male volunteers receive single doses of BI 1358894 with and without food Receives: Drug: BI 1358894 (Test); Drug: BI 1358894 (Reference)

What is being measured

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

Percentage of Subjects With Drug- Related Adverse Event
Percentage of subjects with drug-related adverse events
Measured: From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)

Secondary outcomes (3)

Area Under the Concentration-time Curve of the Analyte BI1358894 in Plasma Over the Time Interval From 0 Extrapolated to Infinity
Area under the concentration-time curve of the analyte BI1358894 in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf)
Measured: Within 2 hours (h) before and 0.167h, 0.333h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 192h after drug administration
Area Under the Concentration-time Curve of the Analyte BI1358894 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Time Point
Area under the concentration-time curve of the analyte BI1358894 in plasma over the time interval from 0 to the last quantifiable data time point (AUC0-tz).
Measured: Within 2 hours (h) before and 0.167h, 0.333h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 192h after drug administration
Maximum Measured Concentration of the Analyte BI 1358894 in Plasma
Maximum measured concentration of the analyte BI 1358894 in plasma (Cmax).
Measured: Within 2 hours (h) before and 0.167h, 0.333h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 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.

18 Jul 201718 Feb 2019

First posted6 Jul 2017
Study start18 Jul 2017
Primary completion18 Feb 2019
Study completion18 Feb 2019

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: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 83 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03210272
Sponsor's protocol ID: 1402-0001
Other IDs: 2017-000143-40, 2017
Status last verified: Mar 2025
First submitted: 5 Jul 2017
Last updated: 25 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Fuertig R, Goettel M, Herich L, Hoefler J, Wiebe ST, Sharma V. Effects of Single and Multiple Ascending Doses of BI 1358894 in Healthy Male Volunteers on Safety, Tolerability and Pharmacokinetics: Two Phase I Partially Randomised Studies. CNS Drugs. 2023 Dec;37(12):1081-1097. doi: 10.1007/s40263-023-01041-4. Epub 2023 Nov 29.
PubMed 38019355

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 25 Mar 2025. 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 1358894 in Healthy Male Subjects (Single-blind, Partially Randomised, Placebo-controlled Parallel Group Design) and Effect of Food on the Relative Bioavailability of BI 1358894 (Open-label, Randomised, Two-way Cross-over)
ClinicalTrials.gov ID: NCT03210272
Acronym / sponsor ID: 1402-0001
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 83 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 18 Jul 2017 (actual)
Primary completion: 18 Feb 2019 (actual)
Study completion: 18 Feb 2019 (actual)
First posted: 6 Jul 2017 (actual)
Results: Posted 25 Mar 2025

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: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Single rising dose part	Experimental	Drug: Placebo, Drug: BI 1358894Group of healthy male volunteers receive rising single doses of BI 1358894
Food effect part	Experimental	Drug: BI 1358894 (Test), Drug: BI 1358894 (Reference)Group of healthy male volunteers receive single doses of BI 1358894 with and without food

Who may qualify

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

Key inclusion criteria (10 listed)

Healthy male according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
Age of 18 to 45 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 GCP and local legislation
Willingness to comply with contraception requirements. Subjects who are sexually active, must use, with their female partner, adequate contraception throughout the study and until one month after the last administration of trial medication. Adequate methods are:

Key exclusion criteria (24 listed)

Any finding in the medical examination (including BP, PR or ECG) is deviating from normal
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
C-Reactive Protein > ULN, erythrocyte sedimentation rate (ESR) ≥ 15 millimeters/hour, liver and kidney parameter above ULN, other laboratory values outside the reference range 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
PlaceboTablet	Drug	Single rising dose part
BI 1358894Tablet	Drug	Single rising dose part
BI 1358894 (Test)Fasting state	Drug	Food effect part
BI 1358894 (Reference)Fed state	Drug	Food effect part

Primary outcome

Percentage of Subjects With Drug- Related Adverse Event
Time frame: From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Percentage of subjects with drug-related adverse events

3 secondary outcomes

Area Under the Concentration-time Curve of the Analyte BI1358894 in Plasma Over the Time Interval From 0 Extrapolated to Infinity
Time frame: Within 2 hours (h) before and 0.167h, 0.333h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 192h after drug administration
Area Under the Concentration-time Curve of the Analyte BI1358894 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Time Point
Time frame: Within 2 hours (h) before and 0.167h, 0.333h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 192h after drug administration
Maximum Measured Concentration of the Analyte BI 1358894 in Plasma
Time frame: Within 2 hours (h) before and 0.167h, 0.333h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 192h after drug administration

Results and safety

Results posted to the registry on 25 Mar 2025, 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	15	15
BI 3mg	6	6
BI 6mg	6	6
BI 10mg	6	6
BI 25mg	6	6
BI 50mg	6	6
BI 100mg	6	6
BI 200mg Fast	6	6
BI 200mg Fed	6	6
BI 50mg Fed / BI 50mg Fast	4	4
BI 50mg Fast / BI 50m Fed	4	4
BI 100mg Fed / BI 100mg Fast	6	6
BI 100mg Fast / BI 100m Fed	6	6

Primary outcome: Percentage of Subjects With Drug- Related Adverse Event

Time frame: From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group). Number. Unit: Percentage

Measure	Placebo n = 15	BI 3mg n = 6	BI 6mg n = 6	BI 10mg n = 6	BI 25mg n = 6	BI 50mg n = 6	BI 100mg n = 6	BI 200mg Fast n = 6	BI 200mg Fed n = 6	BI 50mg Fed n = 8	BI 50mg Fast n = 8	BI 100mg Fed n = 12	BI 100mg Fast n = 12
Value	0.0	16.7	50.0	0.0	33.3	66.7	66.7	50.0	66.7	87.5	87.5	50.0	66.7

Population analysed: Treated Set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.

3 secondary outcomes are reported in the full results.

Adverse events

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 15 (0%)	3 of 15 (20%)	0 of 15
BI 3mg	0 of 6 (0%)	3 of 6 (50%)	0 of 6
BI 6mg	0 of 6 (0%)	6 of 6 (100%)	0 of 6
BI 10mg	0 of 6 (0%)	0 of 6 (0%)	0 of 6
BI 25mg	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
BI 50mg	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
BI 100mg	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
BI 200mg Fast	0 of 6 (0%)	3 of 6 (50%)	0 of 6
BI 200mg Fed	0 of 6 (0%)	6 of 6 (100%)	0 of 6
BI Total SRD	0 of 48 (0%)	28 of 48 (58.3%)	0 of 48
BI 50mg Fed	0 of 8 (0%)	7 of 8 (87.5%)	0 of 8
BI 50mg Fast (R)	0 of 8 (0%)	7 of 8 (87.5%)	0 of 8
BI 100mg Fed (T)	0 of 12 (0%)	6 of 12 (50%)	0 of 12
BI 100mg Fast (R)	0 of 12 (0%)	8 of 12 (66.7%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38019355Fuertig R, Goettel M, Herich L, Hoefler J, Wiebe ST, Sharma V. Effects of Single and Multiple Ascending Doses of BI 1358894 in Healthy Male Volunteers on Safety, Tolerability and Pharmacokinetics: Two Phase I Partially Randomised Studies. CNS Drugs. 2023 Dec;37(12):1081-1097. doi: 10.1007/s40263-023-01041-4. Epub 2023 Nov 29.
Individual participant dataSharing planned: Undecided

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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 BI 1358894, BI 1358894 (Test) and BI 1358894 (Reference) 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 10 inclusion and 24 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 25 Mar 2025. 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 25 Mar 2025). 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 Event (time frame: From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)). 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 NCT03210272, 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 25 Mar 2025.