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CompletedNCT04656288Updated Jul 6, 2026

A Study in Healthy Men to Test if Different Formulations of BI 764198 With or Without Food Influence the Amount of BI 764198 in the Blood

A Phase 1 interventional study of BI 764198 - Formula A and BI 764198 - Formula B in Healthy, sponsored by Boehringer Ingelheim. Completed at 1 site in Belgium. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-06.

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

Phase
Phase 1
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Male
01

Study summary

BI 764198 is intended to be used in patients hospitalized for COVID-19 at risk of respiratory complications. The present trial will investigate the relative bioavailability of BI 764198 administered as capsules versus tablets in a first part, and the relative bioavailability and food effect of four oral formulations: the newly developed tablet formulation under fed and fasted conditions as well as suspension from capsules and suspension from tablets in a second part.

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 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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
  • Age of 18 to 50 years (inclusive) at screening
  • Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive) at screening
  • Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation

  • Male subjects who meet any of the following criteria from first administration of trial medication until 30 days after trial completion:

    • Use of adequate contraception by the female partners, e.g. any of the following methods plus condom: implants, injectables, combined oral or vaginal contraceptives, intrauterine device that started at least 2 months prior to first drug administration to the male subject, or barrier method (e.g. diaphragm with spermicide), or surgically sterilised (including bilateral tubal occlusion, hysterectomy or bilateral oophorectomy), or postmenopausal, defined as at least 1 year of spontaneous amenorrhea
    • Sexually abstinent
    • Vasectomised (vasectomy at least 1 year prior to enrolment) in combination with a barrier method (e.g. condom) Sperm donation is not allowed from first study drug administration until 30 days after trial completion.

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 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.
05

Study design

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

Study arms

  • Experimental
    Formula A under fasted conditions - Part 1

    Drug: BI 764198 - Formula A

  • Experimental
    Formula B under fasted conditions - Part 1

    Drug: BI 764198 - Formula B

  • Experimental
    Formula B under fasted conditions - Part 2

    Drug: BI 764198 - Formula B

  • Experimental
    Formula C under fasted conditions - Part 2

    Drug: BI 764198 - Formula C

  • Experimental
    Formula D under fasted conditions - Part 2

    Drug: BI 764198 - Formula D

  • Experimental
    Formula B under fed conditions - Part 2

    Drug: BI 764198 - Formula B

Interventions

  • DrugBI 764198 - Formula A

    BI 764198

    Also known as: Apecotrep

  • DrugBI 764198 - Formula B

    BI 764198

    Also known as: Apecotrep

  • DrugBI 764198 - Formula C

    BI 764198

    Also known as: Apecotrep

  • DrugBI 764198 - Formula D

    BI 764198

    Also known as: Apecotrep

06

What researchers measure

Primary outcomes

  1. Part 1: AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)

    Time frame: up to 4 days per period

  2. Part 1: Cmax (maximum measured concentration of the analyte in plasma)

    Time frame: up to 4 days per period

  3. Part 2: AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)

    Time frame: up to 5 days per period

  4. Part 2: Cmax (maximum measured concentration of the analyte in plasma)

    Time frame: up to 5 days per period

Secondary outcomes

  1. Part 1: AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

    Time frame: up to 4 days per period

  2. Part 2: AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

    Time frame: up to 5 days per period

07

Study locations

1 site
  • SGS Belgium NV Research Unit Stuivenberg
    Antwerp, 2060, Belgium
08

References and documents

Publications

  • Schultz A, Halabi A, Seitz F, Lemmens K, Wulfrath HS, Lobmeyer MT, Retlich S, Choi W, Soleymanlou N. Phase 1 trials of BI 764198, a transient receptor potential channel 6 inhibitor, in healthy volunteers and participants with kidney impairment. Expert Opin Investig Drugs. 2025 May;34(5):415-423. doi: 10.1080/13543784.2025.2510673. Epub 2025 Jun 8. PubMed 40455255 ↗

Related links

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: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: http://trials.boehringer-ingelheim.com/

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04656288
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Dec 7, 2020
Start date
Jan 15, 2021
Primary completion
Mar 15, 2021
Completion
Mar 15, 2021
Last update
Jul 6, 2026

Oversight

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

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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