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CompletedNCT05155306Updated Feb 26, 2025Results posted

A Study in Healthy People to Compare 2 Different Formulations of BI 1358894 Tablets Taken With or Without Food

A Phase 1 interventional study of BI 1358894, intended Commercial Formulation (iCF) (T) and BI 1358894, Trial Formulation 2 (TFII) (R) in Healthy, sponsored by Boehringer Ingelheim. Completed at 1 site in Germany. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-26.

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

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

To investigate the relative bioavailability of the intended Commercial Formulation (iCF) (Test, T) compared with Trial Formulation 2 (TFII) (Reference, R) and to assess potential food effects following oral administration of BI 1358894.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,297 studies on the registry; 56 are open to participants now.

Of its 166 completed or terminated interventional studies of FDA-regulated products, 121 (73%) have results posted.

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

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Healthy male or female 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
  • Age of 18 to 55 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 International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial

  • Either male subject, or female subject who meet any of the following criteria for a highly effective contraception from at least 30 days before administration of trial medication until 30 days after trial completion:

    • Use of combined (estrogen and progestogen containing) hormonal contraception that prevents ovulation (oral, intravaginal or transdermal), plus one additional barrier
    • Use of progestogen-only hormonal contraception that inhibits ovulation (only injectables or implants), plus one additional barrier
    • Use of intrauterine device (IUD) or intrauterine hormone-releasing system (IUS), plus one additional barrier
    • Sexually abstinent
    • A vasectomised sexual partner who received medical assessment of the surgical success (documented absence of sperm) and provided that partner is the sole sexual partner of the trial participant plus one additional barrier
    • Bilateral tubal ligation plus one additional barrier
    • Surgically sterilised (including hysterectomy, bilateral salpingectomy, bilateral oophorectomy)
    • Postmenopausal, defined as no menses for 1 year without an alternative medical cause (in questionable cases a blood sample with levels of Follicle-stimulating hormone (FSH) above 40 U/L and estradiol below 30 ng/L is confirmatory)

Exclusion criteria

Exclusion Criteria:

  • 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 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 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 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    BI 1358894 - test - fasted

    A single dose of 100 mg (milligram) BI 1358894 given orally as a film-coated tablet in the morning following an overnight fast of at least 10 hours.

    Drug: BI 1358894, intended Commercial Formulation (iCF) (T)

  • Experimental
    BI 1358894 - test - fed

    A single dose of 100 mg (milligram) BI 1358894 given orally as a film-coated tablet in the morning following a high-fat, high-calorie meal.

    Drug: BI 1358894, intended Commercial Formulation (iCF) (T)

  • Experimental
    BI 1358894 - reference - fasted

    A single dose of 100 mg (milligram) BI 1358894 given orally as two 50 mg film-coated tablets in the morning following an overnight fast of at least 10 hours.

    Drug: BI 1358894, Trial Formulation 2 (TFII) (R)

  • Experimental
    BI 1358894 - reference - fed

    A single dose of 00 mg (milligram) BI 1358894 given orally as two 50 mg film-coated tablets in the morning following a high-fat, high-calorie meal.

    Drug: BI 1358894, Trial Formulation 2 (TFII) (R)

Interventions

06

What researchers measure

Primary outcomes

  1. Area Under the Concentration-time Curve of BI 1358894 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)

    Area under the concentration-time curve of BI 1358894 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).

    Time frame: Within 3 hours before and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 34, 48, 72, 96, 120, 144, 240 and 312 hours following drug administration in each treatment period.

  2. Maximum Measured Concentration of BI 1358894 in Plasma (Cmax)

    Maximum measured concentration of BI 1358894 in plasma (Cmax).

    Time frame: Within 3 hours before and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 34, 48, 72, 96, 120, 144, 240 and 312 hours following drug administration in each treatment period.

Secondary outcomes

  1. Area Under the Concentration-time Curve of BI 1358894 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)

    Area under the concentration-time curve of BI 1358894 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).

    Time frame: Within 3 hours before and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 34, 48, 72, 96, 120, 144, 240 and 312 hours following drug administration in each treatment period.

07

Results

Posted Feb 26, 2025

Participant flow

This was a randomised, open-label, single-dose, four-period and four-sequence crossover trial in healthy male and female subjects.

Period 1
Participant flow — Period 1
MilestoneTest Fasted - Reference Fasted - Test Fed - Reference FedReference Fasted - Test Fasted - Reference Fed - Test FedTest Fed - Reference Fed - Reference Fasted - Test FastedReference Fed - Test Fed - Test Fasted - Reference Fasted
Started6666
Completed6666
Not completed0000
Wash-out Period 1 to 2
Participant flow — Wash-out Period 1 to 2
MilestoneTest Fasted - Reference Fasted - Test Fed - Reference FedReference Fasted - Test Fasted - Reference Fed - Test FedTest Fed - Reference Fed - Reference Fasted - Test FastedReference Fed - Test Fed - Test Fasted - Reference Fasted
Started6666
Completed6664
Not completed0002
Withdrew: Adverse event0002
Period 2
Participant flow — Period 2
MilestoneTest Fasted - Reference Fasted - Test Fed - Reference FedReference Fasted - Test Fasted - Reference Fed - Test FedTest Fed - Reference Fed - Reference Fasted - Test FastedReference Fed - Test Fed - Test Fasted - Reference Fasted
Started6664
Completed6664
Not completed0000
Wash-out Period 2 to 3
Participant flow — Wash-out Period 2 to 3
MilestoneTest Fasted - Reference Fasted - Test Fed - Reference FedReference Fasted - Test Fasted - Reference Fed - Test FedTest Fed - Reference Fed - Reference Fasted - Test FastedReference Fed - Test Fed - Test Fasted - Reference Fasted
Started6664
Completed6664
Not completed0000
Period 3
Participant flow — Period 3
MilestoneTest Fasted - Reference Fasted - Test Fed - Reference FedReference Fasted - Test Fasted - Reference Fed - Test FedTest Fed - Reference Fed - Reference Fasted - Test FastedReference Fed - Test Fed - Test Fasted - Reference Fasted
Started6664
Completed6664
Not completed0000
Wash-out Period 3 to 4
Participant flow — Wash-out Period 3 to 4
MilestoneTest Fasted - Reference Fasted - Test Fed - Reference FedReference Fasted - Test Fasted - Reference Fed - Test FedTest Fed - Reference Fed - Reference Fasted - Test FastedReference Fed - Test Fed - Test Fasted - Reference Fasted
Started6664
Completed3553
Not completed3111
Withdrew: Temporal availability3111
Period 4
Participant flow — Period 4
MilestoneTest Fasted - Reference Fasted - Test Fed - Reference FedReference Fasted - Test Fasted - Reference Fed - Test FedTest Fed - Reference Fed - Reference Fasted - Test FastedReference Fed - Test Fed - Test Fasted - Reference Fasted
Started3553
Completed3553
Not completed0000

Outcome measures

PrimaryArea Under the Concentration-time Curve of BI 1358894 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)

Area under the concentration-time curve of BI 1358894 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).

Time frame:
Within 3 hours before and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 34, 48, 72, 96, 120, 144, 240 and 312 hours following drug administration in each treatment period.
Reported as:
Geometric mean · hours*nanomole/Liter
Area Under the Concentration-time Curve of BI 1358894 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
hours*nanomole/LiterBI 1358894 - Test - FastedBI 1358894 - Test - FedBI 1358894 - Reference - FastedBI 1358894 - Reference - Fed
Area Under the Concentration-time Curve of BI 1358894 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)7360 ± 38.714700 ± 26.38430 ± 28.614900 ± 26.6
Statistical analysis
  • BI 1358894 - Test - Fasted vs BI 1358894 - Reference - Fasted · Geometric mean ratio [%]: 89.1 · 90% CI 79.5 to 99.7Ratio is calculated as test/reference. Geometric Standard Error = 1.067.
  • BI 1358894 - Test - Fed vs BI 1358894 - Reference - Fed · Geometric mean ratio [%]: 98.1 · 90% CI 94.4 to 101.9Ratio is calculated as test/reference. Geometric Standard Error = 1.022.
  • BI 1358894 - Test - Fasted vs BI 1358894 - Test - Fed · Geometric mean ratio [%]: 202.4 · 90% CI 180.1 to 227.5Ratio is calculated as fed/fasted. Geometric Standard Error = 1.069.
  • BI 1358894 - Reference - Fasted vs BI 1358894 - Reference - Fed · Geometric mean ratio [%]: 173.8 · 90% CI 158.3 to 190.8Ratio is calculated as fed/fasted. Geometric Standard Error = 1.055.
PrimaryMaximum Measured Concentration of BI 1358894 in Plasma (Cmax)

Maximum measured concentration of BI 1358894 in plasma (Cmax).

Time frame:
Within 3 hours before and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 34, 48, 72, 96, 120, 144, 240 and 312 hours following drug administration in each treatment period.
Reported as:
Geometric mean · nanomole/Liter
Maximum Measured Concentration of BI 1358894 in Plasma (Cmax)
nanomole/LiterBI 1358894 - Fasted - TestBI 1358894 - Fed - TestBI 1358894 - Fasted - ReferenceBI 1358894 - Fed - Reference
Maximum Measured Concentration of BI 1358894 in Plasma (Cmax)292 ± 54.9445 ± 26.1378 ± 52.3440 ± 23.2
Statistical analysis
  • BI 1358894 - Fasted - Test vs BI 1358894 - Fasted - Reference · Geometric mean ratio [%]: 83.0 · 90% CI 69.6 to 99.0Ratio is calculated as test/reference. Geometric Standard Error = 1.106.
  • BI 1358894 - Fed - Test vs BI 1358894 - Fed - Reference · Geometric mean ratio [%]: 99.7 · 90% CI 88.7 to 112.0Ratio is calculated as test/reference. Geometric Standard Error = 1.070.
  • BI 1358894 - Fasted - Test vs BI 1358894 - Fed - Test · Geometric mean ratio [%]: 153.6 · 90% CI 126.0 to 187.3Ratio is calculated as fed/fasted. Geometric Standard Error = 1.121.
  • BI 1358894 - Fasted - Reference vs BI 1358894 - Fed - Reference · Geometric mean ratio [%]: 121.4 · 90% CI 99.6 to 147.8Ratio is calculated as fed/fasted. Geometric Standard Error = 1.120.
SecondaryArea Under the Concentration-time Curve of BI 1358894 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)

Area under the concentration-time curve of BI 1358894 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).

Time frame:
Within 3 hours before and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 34, 48, 72, 96, 120, 144, 240 and 312 hours following drug administration in each treatment period.
Reported as:
Geometric mean · hours*nanomole/Liter
Area Under the Concentration-time Curve of BI 1358894 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
hours*nanomole/LiterBI 1358894 - Fasted - TestBI 1358894 - Fed - TestBI 1358894 - Fasted - ReferenceBI 1358894 - Fed - Reference
Area Under the Concentration-time Curve of BI 1358894 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)8020 ± 37.316100 ± 30.39120 ± 28.015900 ± 28.1
Statistical analysis
  • BI 1358894 - Fasted - Test vs BI 1358894 - Fasted - Reference · Geometric mean ratio [%]: 89.9 · 90% CI 80.4 to 100.4Ratio is calculated as test/reference. Geometric Standard Error = 1.066.
  • BI 1358894 - Fed - Test vs BI 1358894 - Fed - Reference · Geometric mean ratio [%]: 100.4 · 90% CI 96.8 to 104.1Ratio is calculated as test/reference. Geometric Standard Error = 1.021.
  • BI 1358894 - Fasted - Test vs BI 1358894 - Fed - Test · Geometric mean ratio [%]: 202.6 · 90% CI 179.6 to 228.5Ratio is calculated as fed/fasted. Geometric Standard Error = 1.072.
  • BI 1358894 - Fasted - Reference vs BI 1358894 - Fed - Reference · Geometric mean ratio [%]: 172.3 · 90% CI 158.2 to 187.7Ratio is calculated as fed/fasted. Geometric Standard Error = 1.050.

Adverse events

Collected over All-cause Mortality: from time of administration till the end of study (EoS) examination, time of next administration or trial termination. Up to 25 days. Adverse events: from time of administration till the end of the residual effect period, time of next administration or trial termination, whichever occurs first. Up to 17 days.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
BI 1358894 - Reference - Fasted0/21 (0%)0/21 (0%)15/21 (71.4%)
BI 1358894 - Reference - Fed0/21 (0%)0/21 (0%)13/21 (61.9%)
BI 1358894 - Test - Fasted0/21 (0%)0/21 (0%)13/21 (61.9%)
BI 1358894 - Test - Fed0/21 (0%)0/21 (0%)13/21 (61.9%)
Most frequent other events
Most frequent other events
EventBI 1358894 - Reference - FastedBI 1358894 - Reference - FedBI 1358894 - Test - FastedBI 1358894 - Test - Fed
HeadacheNervous system disorders14/2113/2112/2110/21
COVID-19Infections and infestations3/211/211/213/21
DizzinessNervous system disorders0/211/212/210/21
Subcutaneous haematomaInjury, poisoning and procedural complications2/210/210/210/21
PollakiuriaRenal and urinary disorders2/211/211/210/21

Baseline characteristics

Treated set: All subjects who were treated with at least one dose of the trial drug.

Age, Continuous
Age, Continuous(years)Test Fasted - Reference Fasted - Test Fed - Reference FedReference Fasted - Test Fasted - Reference Fed - Test FedTest Fed - Reference Fed - Reference Fasted - Test FastedReference Fed - Test Fed - Test Fasted - Reference FastedTotal
Mean43.0 ± 6.536.2 ± 7.544.5 ± 13.034.2 ± 6.039.5 ± 9.3
Sex: Female, Male
Sex: Female, Male(Participants)Test Fasted - Reference Fasted - Test Fed - Reference FedReference Fasted - Test Fasted - Reference Fed - Test FedTest Fed - Reference Fed - Reference Fasted - Test FastedReference Fed - Test Fed - Test Fasted - Reference FastedTotal
Female13138
Male535316
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Test Fasted - Reference Fasted - Test Fed - Reference FedReference Fasted - Test Fasted - Reference Fed - Test FedTest Fed - Reference Fed - Reference Fasted - Test FastedReference Fed - Test Fed - Test Fasted - Reference FastedTotal
Hispanic or Latino00000
Not Hispanic or Latino666624
Unknown or Not Reported00000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Test Fasted - Reference Fasted - Test Fed - Reference FedReference Fasted - Test Fasted - Reference Fed - Test FedTest Fed - Reference Fed - Reference Fasted - Test FastedReference Fed - Test Fed - Test Fasted - Reference FastedTotal
American Indian or Alaska Native00000
Asian00000
Native Hawaiian or Other Pacific Islander00000
Black or African American00000
White666624
More than one race00000
Unknown or Not Reported00000
08

Study locations

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

References and documents

Related links

Study documents

  • Study protocol · Apr 20, 2022
  • Statistical analysis plan · Jun 16, 2022

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, except for the following exclusions: 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 (because of limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datasharing

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05155306
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Dec 13, 2021
Start date
Jan 14, 2022
Primary completion
May 16, 2022
Completion
May 16, 2022
Results posted
Feb 26, 2025
Last update
Feb 26, 2025

Oversight

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

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