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CompletedNCT05945888Updated Jun 8, 2026Results posted

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 interventional study of BI 3000202 and Placebo matching BI 3000202 in Healthy, sponsored by Boehringer Ingelheim. Completed at 1 site in Germany. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-08.

Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  1. 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
  2. Age of 18 to 45 years (inclusive)
  3. Body mass index (BMI) of 18.5 to 29.9 kg/m\^2 (inclusive)
  4. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial

Exclusion criteria

Exclusion criteria

  1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
  2. 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)
  3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
  4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator
  5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  6. Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
  7. Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
  8. History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
68 participants (actual)

Study arms

  • Placebo comparator
    Single rising dose (SRD): Placebo matching BI 3000202

    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).

    Drug: BI 3000202

  • Experimental
    SRD: Dose 1 - BI 3000202

    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.

    Drug: BI 3000202 · Drug: Placebo matching BI 3000202

  • Experimental
    SRD: Dose 2 - BI 3000202

    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.

    Drug: BI 3000202

  • Experimental
    SRD: Dose 3 - BI 3000202

    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.

    Drug: BI 3000202

  • Experimental
    SRD: Dose 4 - BI 3000202

    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.

    Drug: BI 3000202

  • Experimental
    SRD: Dose 5 - BI 3000202

    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.

    Drug: BI 3000202

  • Experimental
    SRD: Dose 6 - BI 3000202

    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.

    Drug: BI 3000202

  • Experimental
    SRD: Dose 7 - BI 3000202

    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.

    Drug: BI 3000202

  • Experimental
    Food effect (FE): Low dose III BI 3000202 fasted (R) / fed (T)

    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.

    Drug: BI 3000202

  • Experimental
    FE: Low dose III BI 3000202 fed (T) / fasted (R)

    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.

    Drug: BI 3000202

Interventions

  • DrugBI 3000202

    BI 3000202

  • DrugPlacebo matching BI 3000202

    Placebo matching BI 3000202

06

What researchers measure

Primary outcomes

  1. 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.

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

  2. 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'.

    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

  3. 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'.

    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

Secondary outcomes

  1. 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.

    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

  2. SRD Part: Maximum Measured Concentration of BI 3000202 in Plasma (Cmax)

    Maximum measured concentration of BI 3000202 in plasma was analyzed descriptively.

    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

  3. 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'.

    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

07

Results

Posted Jun 8, 2026

Participant flow

This trial consisted of two parts, a single rising dose (SRD) part and food effect (FE) part in healthy men. The SRD part was a randomized, single-blind, and placebo-controlled trial, while the FE part was randomized, open-label, single dose, and two-way cross-over. The subjects in the SRD part were mutually exclusive with those in the FE part.

Participant flow — Overall Study
MilestoneSingle Rising Dose (SRD): Placebo Matching BI 3000202SRD: Dose 1 - BI 3000202SRD: Dose 2 - BI 3000202SRD: Dose 3 - BI 3000202SRD: Dose 4 - BI 3000202SRD: Dose 5 - BI 3000202SRD: Dose 6 - BI 3000202SRD: Dose 7 - BI 3000202Food Effect (FE): Low Dose III BI 3000202 Fasted (R) / Fed (T)FE: Low Dose III BI 3000202 Fed (T) / Fasted (R)
Started14666666666
Completed14666666666
Not completed0000000000

Outcome measures

PrimarySRD 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.

Time frame:
From drug administration on Day 1 plus REP of 48 hours, up to 2 days.
Reported as:
Count of participants · Participants
SRD Part: Number of Any Treatment-emergent Adverse Event Assessed as Drug-related by the Investigator
ParticipantsSingle Rising Dose (SRD): Placebo Matching BI 3000202SRD: Dose 1 - BI 3000202SRD: Dose 2 - BI 3000202SRD: Dose 3 - BI 3000202SRD: Dose 4 - BI 3000202SRD: Dose 5 - BI 3000202SRD: Dose 6 - BI 3000202SRD: Dose 7 - BI 3000202
SRD Part: Number of Any Treatment-emergent Adverse Event Assessed as Drug-related by the Investigator10010000
PrimaryFE 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'.

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
Reported as:
Geometric least squares mean · Nanomoles times hour per Liter
FE Part: Area Under the Concentration-time Curve of BI 3000202 in Plasma Over the Dosing Interval 0 to 24 Hours (AUC0-24)
Nanomoles times hour per LiterFood Effect (FE): Low Dose III BI 3000202 Fasted (= Reference R)FE Part: Low Dose III BI 3000202 Fed (= Test T)
FE Part: Area Under the Concentration-time Curve of BI 3000202 in Plasma Over the Dosing Interval 0 to 24 Hours (AUC0-24)901.43 ± NA768.45 ± NA
Statistical analysis
  • 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 101.30Intra-individual geometric coefficient of variation (gCV%) = 21.1
PrimaryFE 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'.

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
Reported as:
Geometric least squares mean · Nanomoles per Liter
FE Part: Maximum Measured Concentration of BI 3000202 in Plasma (Cmax)
Nanomoles per LiterFood Effect (FE): Low Dose III BI 3000202 Fasted (= Reference R)FE Part: Low Dose III BI 3000202 Fed (= Test T)
FE Part: Maximum Measured Concentration of BI 3000202 in Plasma (Cmax)229.43 ± NA219.06 ± NA
Statistical analysis
  • 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 139.41Intra-individual geometric coefficient of variation (gCV%) = 48.9
SecondarySRD 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.

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
Reported as:
Geometric mean · Nanomoles times hour per Liter
SRD Part: Area Under the Concentration-time Curve of BI 3000202 in Plasma Over the Dosing Interval 0 to 24 Hours (AUC0-24)
Nanomoles times hour per LiterSRD: Dose 1 - BI 3000202SRD: Dose 2 - BI 3000202SRD: Dose 3 - BI 3000202SRD: Dose 4 - BI 3000202SRD: Dose 5 - BI 3000202SRD: Dose 6 - BI 3000202SRD: Dose 7 - BI 3000202
SRD Part: Area Under the Concentration-time Curve of BI 3000202 in Plasma Over the Dosing Interval 0 to 24 Hours (AUC0-24)115 ± 28.8386 ± 25.81610 ± 35.22570 ± 56.84330 ± 85.98440 ± 31.012500 ± 49.6
SecondarySRD Part: Maximum Measured Concentration of BI 3000202 in Plasma (Cmax)

Maximum measured concentration of BI 3000202 in plasma was analyzed descriptively.

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
Reported as:
Geometric mean · Nanomoles times hour per Liter
SRD Part: Maximum Measured Concentration of BI 3000202 in Plasma (Cmax)
Nanomoles times hour per LiterSRD: Dose 1 - BI 3000202SRD: Dose 2 - BI 3000202SRD: Dose 3 - BI 3000202SRD: Dose 4 - BI 3000202SRD: Dose 5 - BI 3000202SRD: Dose 6 - BI 3000202SRD: Dose 7 - BI 3000202
SRD Part: Maximum Measured Concentration of BI 3000202 in Plasma (Cmax)48.8 ± 63.165.0 ± 87.4535 ± 42.5614 ± 52.91270 ± 84.62430 ± 43.73670 ± 63.1
SecondaryFE 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'.

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
Reported as:
Geometric least squares mean · Nanomoles times hour per Liter
FE Part: Area Under the Concentration-time Curve of BI 3000202 in Plasma Over the Dosing Interval 0 to Infinity (AUC0-∞)
Nanomoles times hour per LiterFood Effect (FE): Low Dose III BI 3000202 Fasted (= Reference R)FE Part: Low Dose III BI 3000202 Fed (= Test T)
FE Part: Area Under the Concentration-time Curve of BI 3000202 in Plasma Over the Dosing Interval 0 to Infinity (AUC0-∞)1020.66 ± NA842.69 ± NA
Statistical analysis
  • 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) [%]: 82.56 · 90% CI 70.27 to 97.01Intra-individual geometric coefficient of variation (gCV%) = 19.6

Adverse events

Collected over 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).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Single Rising Dose (SRD): Placebo Matching BI 30002020/14 (0%)0/14 (0%)3/14 (21.4%)
SRD: Dose 1 - BI 30002020/6 (0%)0/6 (0%)0/6 (0%)
SRD: Dose 2 - BI 30002020/6 (0%)0/6 (0%)0/6 (0%)
SRD: Dose 3 - BI 30002020/6 (0%)0/6 (0%)1/6 (16.7%)
SRD: Dose 4 - BI 30002020/6 (0%)0/6 (0%)0/6 (0%)
SRD: Dose 5 - BI 30002020/6 (0%)0/6 (0%)0/6 (0%)
SRD: Dose 6 - BI 30002020/6 (0%)0/6 (0%)1/6 (16.7%)
SRD: Dose 7 - BI 30002020/6 (0%)0/6 (0%)0/6 (0%)
Food Effect (FE): Low Dose III BI 3000202 Fasted (= Reference R)0/12 (0%)0/12 (0%)2/12 (16.7%)
FE Part: Low Dose III BI 3000202 Fed (= Test T)0/12 (0%)0/12 (0%)1/12 (8.3%)
Most frequent other events
Most frequent other events
EventSingle Rising Dose (SRD): Placebo Matching BI 3000202SRD: Dose 1 - BI 3000202SRD: Dose 2 - BI 3000202SRD: Dose 3 - BI 3000202SRD: Dose 4 - BI 3000202SRD: Dose 5 - BI 3000202SRD: Dose 6 - BI 3000202SRD: Dose 7 - BI 3000202Food Effect (FE): Low Dose III BI 3000202 Fasted (= Reference R)FE Part: Low Dose III BI 3000202 Fed (= Test T)
DiarrhoeaGastrointestinal disorders1/140/60/60/60/60/61/60/60/120/12
HeadacheNervous system disorders2/140/60/61/60/60/60/60/62/121/12
NauseaGastrointestinal disorders0/140/60/60/60/60/60/60/61/120/12
Abdominal pain lowerGastrointestinal disorders1/140/60/60/60/60/60/60/60/120/12
Medical device site rashGeneral disorders1/140/60/60/60/60/60/60/60/120/12

Baseline characteristics

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

Age, Continuous
Age, Continuous(Years)Single Rising Dose (SRD): Placebo Matching BI 3000202SRD: Dose 1 - BI 3000202SRD: Dose 2 - BI 3000202SRD: Dose 3 - BI 3000202SRD: Dose 4 - BI 3000202SRD: Dose 5 - BI 3000202SRD: Dose 6 - BI 3000202SRD: Dose 7 - BI 3000202Food Effect (FE): Low Dose III BI 3000202 Fasted (R) / Fed (T)FE: Low Dose III BI 3000202 Fed (T) / Fasted (R)Total
Mean30.1 ± 6.735.7 ± 3.935.2 ± 7.430.2 ± 8.825.2 ± 4.536.2 ± 4.536.5 ± 8.530.2 ± 7.434.7 ± 5.129.7 ± 7.032.1 ± 7.1
Sex: Female, Male
Sex: Female, Male(Participants)Single Rising Dose (SRD): Placebo Matching BI 3000202SRD: Dose 1 - BI 3000202SRD: Dose 2 - BI 3000202SRD: Dose 3 - BI 3000202SRD: Dose 4 - BI 3000202SRD: Dose 5 - BI 3000202SRD: Dose 6 - BI 3000202SRD: Dose 7 - BI 3000202Food Effect (FE): Low Dose III BI 3000202 Fasted (R) / Fed (T)FE: Low Dose III BI 3000202 Fed (T) / Fasted (R)Total
Female00000000000
Male1466666666668
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Single Rising Dose (SRD): Placebo Matching BI 3000202SRD: Dose 1 - BI 3000202SRD: Dose 2 - BI 3000202SRD: Dose 3 - BI 3000202SRD: Dose 4 - BI 3000202SRD: Dose 5 - BI 3000202SRD: Dose 6 - BI 3000202SRD: Dose 7 - BI 3000202Food Effect (FE): Low Dose III BI 3000202 Fasted (R) / Fed (T)FE: Low Dose III BI 3000202 Fed (T) / Fasted (R)Total
Hispanic or Latino00000000000
Not Hispanic or Latino1466666666668
Unknown or Not Reported00000000000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Single Rising Dose (SRD): Placebo Matching BI 3000202SRD: Dose 1 - BI 3000202SRD: Dose 2 - BI 3000202SRD: Dose 3 - BI 3000202SRD: Dose 4 - BI 3000202SRD: Dose 5 - BI 3000202SRD: Dose 6 - BI 3000202SRD: Dose 7 - BI 3000202Food Effect (FE): Low Dose III BI 3000202 Fasted (R) / Fed (T)FE: Low Dose III BI 3000202 Fed (T) / Fasted (R)Total
American Indian or Alaska Native00000000000
Asian00100000001
Native Hawaiian or Other Pacific Islander00000000000
Black or African American00000000000
White1465665666666
More than one race00000100001
Unknown or Not Reported00000000000
08

Study locations

1 site
  • Humanpharmakologisches Zentrum Biberach
    Biberach, 88397, Germany
09

References and documents

Related links

Study documents

  • Study protocol · May 25, 2023
  • Statistical analysis plan · Dec 15, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: 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

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05945888
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Jul 14, 2023
Start date
Jul 25, 2023
Primary completion
Nov 13, 2023
Completion
Nov 13, 2023
Results posted
Jun 8, 2026
Last update
Jun 8, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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