HealthyPhase 1NCT05945888

A Study in Healthy Men to Test How Different Doses of BI 3000202 Are Tolerated and How Food Influences the Amount of BI 3000202 in the Blood

A Phase 1 study testing BI 3000202 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 single rising dose (SRD) part of the trial investigates safety, tolerability, and pharmacokinetics of BI 3000202. The food effect (FE) part is conducted to assess the effect of food on the relative bioavailability of the BI 3000202 formulation. 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 3000202
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 68 participants
Where: 1 siteGermany
Study dates: 25 Jul 2023to 13 Nov 2023
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 according to the assessment of the investigator, as 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 without any clinically significant abnormalities
Age of 18 to 45 years (inclusive)
Body mass index (BMI) of 18.5 to 29.9 kg/m^2 (inclusive)
Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial

Who cannot join

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

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: A Randomised, Single-blind, Placebo-controlled Trial to Investigate Safety, Tolerability, and Pharmacokinetics of Single Rising Doses of BI 3000202 Administered as Tablet to Healthy Male Subjects, and a Randomised, Open-label, Single-dose, Two-way Cross-over Relative Bioavailability Comparison of BI 3000202 as Tablet With and Without Food in Healthy Male Subjects

The single rising dose (SRD) part of the trial investigates safety, tolerability, and pharmacokinetics of BI 3000202.

The food effect (FE) part is conducted to assess the effect of food on the relative bioavailability of the BI 3000202 formulation.

Conditions: Healthy
Being tested: BI 3000202, Placebo matching BI 3000202

What participants receive

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

BI 3000202Drug
BI 3000202
Placebo matching BI 3000202Drug
Placebo matching BI 3000202

Study groups in NCT05945888
Study group	Role	What they receive
Single rising dose (SRD): Placebo matching BI 3000202	Placebo comparator	SRD part: A single administration of 1 film-coated tablet identical to the active BI 3000202 treatment was orally given with 240 milliliters (mL) of water after an overnight fast of at least 10 hours (h). Receives: Drug: BI 3000202
SRD: Dose 1 - BI 3000202	Experimental	SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 1) was administered orally with 240 mL of water after a minimum 10-hour overnight fast. Receives: Drug: BI 3000202; Drug: Placebo matching BI 3000202
SRD: Dose 2 - BI 3000202	Experimental	SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 2) was administered orally with 240 mL of water after a minimum 10-hour overnight fast. Receives: Drug: BI 3000202
SRD: Dose 3 - BI 3000202	Experimental	SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 3) was administered orally with 240 mL of water after a minimum 10-hour overnight fast. Receives: Drug: BI 3000202
SRD: Dose 4 - BI 3000202	Experimental	SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 4) was administered orally with 240 mL of water after a minimum 10-hour overnight fast. Receives: Drug: BI 3000202
SRD: Dose 5 - BI 3000202	Experimental	SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 5) was administered orally with 240 mL of water after a minimum 10-hour overnight fast. Receives: Drug: BI 3000202
SRD: Dose 6 - BI 3000202	Experimental	SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 6) was administered orally with 240 mL of water after a minimum 10-hour overnight fast. Receives: Drug: BI 3000202
SRD: Dose 7 - BI 3000202	Experimental	SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 7) was administered orally with 240 mL of water after a minimum 10-hour overnight fast. Receives: Drug: BI 3000202
Food effect (FE): Low dose III BI 3000202 fasted (R) / fed (T)	Experimental	FE part: In treatment Period 1, participants received a low dose III film-coated tablet BI 3000202, orally administered with 240 mL of water after an overnight fast of at least 10 hours (= reference R). In treatment Period 2, participants received a low dose III film-coated tablet BI 3000202, orally administered with 240 mL of water 30 minutes after consuming a high-fat, high-calorie breakfast consumed after an overnight fast of at least 10 hours (=test T). There was a minimum 3-day washout period between the two treatments. Receives: Drug: BI 3000202
FE: Low dose III BI 3000202 fed (T) / fasted (R)	Experimental	FE part: In treatment Period 1, participants received a low dose III film-coated tablet BI 3000202, orally administered with 240 mL of water 30 minutes after consuming a high-fat, high-calorie breakfast consumed after an overnight fast of at least 10 hours (=test T). In treatment Period 2, participants received a low dose III film-coated tablet BI 3000202, orally administered with 240 mL of water 30 minutes after an overnight fast of at least 10 hours (= reference R). There was a minimum 3-day washout period between the two treatments. Receives: Drug: BI 3000202

What is being measured

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

SRD Part: Number of Any Treatment-emergent Adverse Event Assessed as Drug-related by the Investigator
Number of any treatment-emergent adverse event assessed as drug-related by the investigator.
Percentages were calculated using the total number of participants per treatment as denominator.
MedDRA version 26.1 was used for reporting. All adverse events occurring up to 48 hours (2 days) after drug administration were assigned to treatment.
Medical judgment was used to determine whether there was a reasonable possibility of a causal relationship between the AE and the given trial treatment, considering all relevant factors, including pattern of reaction, temporal relationship, de-challenge or re-challenge, confounding factors such as concomitant medication, concomitant diseases and relevant history.
Measured: From drug administration on Day 1 plus REP of 48 hours, up to 2 days.
FE Part: Area Under the Concentration-time Curve of BI 3000202 in Plasma Over the Dosing Interval 0 to 24 Hours (AUC0-24)
Area under the concentration-time curve of BI 3000202 in plasma over the dosing interval 0 to 24 hours (AUC0-24). The AUC0-24 endpoint was log-transformed (natural logarithm) prior to fitting the Analysis of Variance (ANOVA) model.
The ANOVA model accounted for the random effect 'participants within sequences' and fixed effects 'sequence' 'period' and 'treatment'.
Measured: Within 3 hours (h) prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48 h after drug administration
FE Part: Maximum Measured Concentration of BI 3000202 in Plasma (Cmax)
Maximum measured concentration of BI 3000202 in plasma (Cmax). The Cmax endpoint was log-transformed (natural logarithm) prior to fitting the Analysis of Variance (ANOVA) model.
The ANOVA model accounted for the random effect 'participants within sequences' and the fixed effects 'sequence' 'period' and 'treatment'.
Measured: Within 3 hours (h) prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48 h after drug administration

Secondary outcomes (3)

SRD Part: Area Under the Concentration-time Curve of BI 3000202 in Plasma Over the Dosing Interval 0 to 24 Hours (AUC0-24)
Area under the concentration-time curve of BI 3000202 in plasma over the dosing interval 0 to 24 hours (AUC0-24) was analyzed descriptively.
Measured: Within 3 hours (h) prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48 h after drug administration
SRD Part: Maximum Measured Concentration of BI 3000202 in Plasma (Cmax)
Maximum measured concentration of BI 3000202 in plasma was analyzed descriptively.
Measured: Within 3 hours (h) prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48 h after drug administration
FE Part: Area Under the Concentration-time Curve of BI 3000202 in Plasma Over the Dosing Interval 0 to Infinity (AUC0-∞)
Area under the concentration-time curve of BI 3000202 in plasma over the dosing interval 0 to infinity (AUC0-∞).
The AUC0-∞ endpoint was log-transformed (natural logarithm) prior to fitting the Analysis of Variance (ANOVA) model.
The ANOVA model accounted for the random effect 'participants within sequences' and the fixed effects 'sequence' 'period' and 'treatment'.
Measured: Within 3 hours (h) prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48 h after drug administration

Timeline

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

25 Jul 202313 Nov 2023

First posted14 Jul 2023
Study start25 Jul 2023
Primary completion13 Nov 2023
Study completion13 Nov 2023

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.
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
Model description: The SRD part of the trial is designed as blinded to subjects, randomised, and placebo-controlled within parallel dose groups. In the FE part, subjects participate in a randomised, open-label, two-way crossover trial part with two treatment periods.
Masking: Single blind
Who is masked: Participant
Enrolment: 68 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05945888
Sponsor's protocol ID: 1509-0001
Other IDs: 2022-502424-43-00
Status last verified: May 2026
First submitted: 7 Jul 2023
Last updated: 8 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
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.mystudywindow.com/msw/datatransparency

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

Official title: A Randomised, Single-blind, Placebo-controlled Trial to Investigate Safety, Tolerability, and Pharmacokinetics of Single Rising Doses of BI 3000202 Administered as Tablet to Healthy Male Subjects, and a Randomised, Open-label, Single-dose, Two-way Cross-over Relative Bioavailability Comparison of BI 3000202 as Tablet With and Without Food in Healthy Male Subjects
ClinicalTrials.gov ID: NCT05945888
Acronym / sponsor ID: 1509-0001
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 68 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 25 Jul 2023 (actual)
Primary completion: 13 Nov 2023 (actual)
Study completion: 13 Nov 2023 (actual)
First posted: 14 Jul 2023 (actual)
Results: Posted 8 Jun 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The single rising dose (SRD) part of the trial investigates safety, tolerability, and pharmacokinetics of BI 3000202.

The food effect (FE) part is conducted to assess the effect of food on the relative bioavailability of the BI 3000202 formulation.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 10
Model description: The SRD part of the trial is designed as blinded to subjects, randomised, and placebo-controlled within parallel dose groups. In the FE part, subjects participate in a randomised, open-label, two-way crossover trial part with two treatment periods.

Arm	Type	Receives
Single rising dose (SRD): Placebo matching BI 3000202	Placebo comparator	Drug: BI 3000202SRD part: A single administration of 1 film-coated tablet identical to the active BI 3000202 treatment was orally given with 240 milliliters (mL) of water after an overnight fast of at least 10 hours (h).
SRD: Dose 1 - BI 3000202	Experimental	Drug: BI 3000202, Drug: Placebo matching BI 3000202SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 1) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
SRD: Dose 2 - BI 3000202	Experimental	Drug: BI 3000202SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 2) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
SRD: Dose 3 - BI 3000202	Experimental	Drug: BI 3000202SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 3) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
SRD: Dose 4 - BI 3000202	Experimental	Drug: BI 3000202SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 4) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
SRD: Dose 5 - BI 3000202	Experimental	Drug: BI 3000202SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 5) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
SRD: Dose 6 - BI 3000202	Experimental	Drug: BI 3000202SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 6) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
SRD: Dose 7 - BI 3000202	Experimental	Drug: BI 3000202SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 7) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
Food effect (FE): Low dose III BI 3000202 fasted (R) / fed (T)	Experimental	Drug: BI 3000202FE part: In treatment Period 1, participants received a low dose III film-coated tablet BI 3000202, orally administered with 240 mL of water after an overnight fast of at least 10 hours (= reference R). In treatment Period 2, participants received a low dose III film-coated tablet BI 3000202, orally administered with 240 mL of water 30 minutes after consuming a high-fat, high-calorie breakfast consumed after an overnight fast of at least 10 hours (=test T). There was a minimum 3-day washout period between the two treatments.
FE: Low dose III BI 3000202 fed (T) / fasted (R)	Experimental	Drug: BI 3000202FE part: In treatment Period 1, participants received a low dose III film-coated tablet BI 3000202, orally administered with 240 mL of water 30 minutes after consuming a high-fat, high-calorie breakfast consumed after an overnight fast of at least 10 hours (=test T). In treatment Period 2, participants received a low dose III film-coated tablet BI 3000202, orally administered with 240 mL of water 30 minutes after an overnight fast of at least 10 hours (= reference R). There was a minimum 3-day washout period between the two treatments.

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 according to the assessment of the investigator, as 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 without any clinically significant abnormalities
Age of 18 to 45 years (inclusive)
Body mass index (BMI) of 18.5 to 29.9 kg/m^2 (inclusive)
Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial

Key exclusion criteria (8 listed)

Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimeter of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm)
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
Any evidence of a concomitant disease assessed 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 3000202BI 3000202	Drug	FE: Low dose III BI 3000202 fed (T) / fasted (R), Food effect (FE): Low dose III BI 3000202 fasted (R) / fed (T), SRD: Dose 1 - BI 3000202, SRD: Dose 2 - BI 3000202, SRD: Dose 3 - BI 3000202, SRD: Dose 4 - BI 3000202, SRD: Dose 5 - BI 3000202, SRD: Dose 6 - BI 3000202, SRD: Dose 7 - BI 3000202, Single rising dose (SRD): Placebo matching BI 3000202
Placebo matching BI 3000202Placebo matching BI 3000202	Drug	SRD: Dose 1 - BI 3000202

Primary outcome

SRD Part: Number of Any Treatment-emergent Adverse Event Assessed as Drug-related by the Investigator
Time frame: From drug administration on Day 1 plus REP of 48 hours, up to 2 days.
Number of any treatment-emergent adverse event assessed as drug-related by the investigator. Percentages were calculated using the total number of participants per treatment as denominator. MedDRA version 26.1 was used for reporting. All adverse events occurring up to 48 hours (2 days) after drug administration were assigned to treatment. Medical judgment was used to determine whether there was a reasonable possibility of a causal relationship between the AE and the given trial treatment, considering all relevant factors, including pattern of reaction, temporal relationship, de-challenge or re-challenge, confounding factors such as concomitant medication, concomitant diseases and relevant history.
FE Part: Area Under the Concentration-time Curve of BI 3000202 in Plasma Over the Dosing Interval 0 to 24 Hours (AUC0-24)
Time frame: Within 3 hours (h) prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48 h after drug administration
Area under the concentration-time curve of BI 3000202 in plasma over the dosing interval 0 to 24 hours (AUC0-24). The AUC0-24 endpoint was log-transformed (natural logarithm) prior to fitting the Analysis of Variance (ANOVA) model. The ANOVA model accounted for the random effect 'participants within sequences' and fixed effects 'sequence' 'period' and 'treatment'.
FE Part: Maximum Measured Concentration of BI 3000202 in Plasma (Cmax)
Time frame: Within 3 hours (h) prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48 h after drug administration
Maximum measured concentration of BI 3000202 in plasma (Cmax). The Cmax endpoint was log-transformed (natural logarithm) prior to fitting the Analysis of Variance (ANOVA) model. The ANOVA model accounted for the random effect 'participants within sequences' and the fixed effects 'sequence' 'period' and 'treatment'.

3 secondary outcomes

SRD Part: Area Under the Concentration-time Curve of BI 3000202 in Plasma Over the Dosing Interval 0 to 24 Hours (AUC0-24)
Time frame: Within 3 hours (h) prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48 h after drug administration
SRD Part: Maximum Measured Concentration of BI 3000202 in Plasma (Cmax)
Time frame: Within 3 hours (h) prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48 h after drug administration
FE Part: Area Under the Concentration-time Curve of BI 3000202 in Plasma Over the Dosing Interval 0 to Infinity (AUC0-∞)
Time frame: Within 3 hours (h) prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48 h after drug administration

Results and safety

Results posted to the registry on 8 Jun 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
Single Rising Dose (SRD): Placebo Matching BI 3000202	14	14
SRD: Dose 1 - BI 3000202	6	6
SRD: Dose 2 - BI 3000202	6	6
SRD: Dose 3 - BI 3000202	6	6
SRD: Dose 4 - BI 3000202	6	6
SRD: Dose 5 - BI 3000202	6	6
SRD: Dose 6 - BI 3000202	6	6
SRD: Dose 7 - BI 3000202	6	6
Food Effect (FE): Low Dose III BI 3000202 Fasted (R) / Fed (T)	6	6
FE: Low Dose III BI 3000202 Fed (T) / Fasted (R)	6	6

Primary outcome: SRD Part: Number of Any Treatment-emergent Adverse Event Assessed as Drug-related by the Investigator

Time frame: From drug administration on Day 1 plus REP of 48 hours, up to 2 days.. Count of participants. Unit: Participants

Measure	Single Rising Dose (SRD): Placebo Matching BI 3000202 n = 14	SRD: Dose 1 - BI 3000202 n = 6	SRD: Dose 2 - BI 3000202 n = 6	SRD: Dose 3 - BI 3000202 n = 6	SRD: Dose 4 - BI 3000202 n = 6	SRD: Dose 5 - BI 3000202 n = 6	SRD: Dose 6 - BI 3000202 n = 6	SRD: Dose 7 - BI 3000202 n = 6
Value	1	0	0	1	0	0	0	0

Population analysed: Treated set (TS): The TS includes all participants who were treated with at least one dose of the trial drug.

Primary outcome: FE Part: Area Under the Concentration-time Curve of BI 3000202 in Plasma Over the Dosing Interval 0 to 24 Hours (AUC0-24)

Time frame: Within 3 hours (h) prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48 h after drug administration. Geometric least squares mean (Standard Error). Unit: Nanomoles times hour per Liter

Measure	Food Effect (FE): Low Dose III BI 3000202 Fasted (= Reference R) n = 10	FE Part: Low Dose III BI 3000202 Fed (= Test T) n = 12
Value	901.43 (NA)	768.45 (NA)

Food Effect (FE): Low Dose III BI 3000202 Fasted (= Reference R) vs FE Part: Low Dose III BI 3000202 Fed (= Test T): Geometric mean ratio (T/R) [%]: 85.25 (90% CI 71.74 to 101.30)

Population analysed: Pharmacokintetic (PK) parameter analysis set (PKS): This set included all participants in the treated set (TS) who provided at least one PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.

Primary outcome: FE Part: Maximum Measured Concentration of BI 3000202 in Plasma (Cmax)

Measure	Food Effect (FE): Low Dose III BI 3000202 Fasted (= Reference R) n = 10	FE Part: Low Dose III BI 3000202 Fed (= Test T) n = 12
Value	229.43 (NA)	219.06 (NA)

Food Effect (FE): Low Dose III BI 3000202 Fasted (= Reference R) vs FE Part: Low Dose III BI 3000202 Fed (= Test T): Geometric mean ratio (T/R) [%]: 95.48 (90% CI 65.40 to 139.41)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events: SRD & FE Part: from drug administration on Day 1, up to 2 days. All-Cause Mortality, from drug administration on Day 1 - until next drug administration or (FE only) - or end of trial, up to 14 days (SRD &FE).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Single Rising Dose (SRD): Placebo Matching BI 3000202	0 of 14 (0%)	3 of 14 (21.4%)	0 of 14
SRD: Dose 1 - BI 3000202	0 of 6 (0%)	0 of 6 (0%)	0 of 6
SRD: Dose 2 - BI 3000202	0 of 6 (0%)	0 of 6 (0%)	0 of 6
SRD: Dose 3 - BI 3000202	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
SRD: Dose 4 - BI 3000202	0 of 6 (0%)	0 of 6 (0%)	0 of 6
SRD: Dose 5 - BI 3000202	0 of 6 (0%)	0 of 6 (0%)	0 of 6
SRD: Dose 6 - BI 3000202	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
SRD: Dose 7 - BI 3000202	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Food Effect (FE): Low Dose III BI 3000202 Fasted (= Reference R)	0 of 12 (0%)	2 of 12 (16.7%)	0 of 12
FE Part: Low Dose III BI 3000202 Fed (= Test T)	0 of 12 (0%)	1 of 12 (8.3%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.mystudywindow.com/msw/datatransparency

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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 3000202 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 8 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 8 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 8 Jun 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?

SRD Part: Number of Any Treatment-emergent Adverse Event Assessed as Drug-related by the Investigator (time frame: From drug administration on Day 1 plus REP of 48 hours, up to 2 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 NCT05945888.

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 8 Jun 2026.