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HealthyPhase 1NCT04656288

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 study testing BI 764198 - Formula A, BI 764198 - Formula B and BI 764198 - Formula C in people with Healthy, run by Boehringer Ingelheim at 1 site in Belgium.

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

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… Read more about this study

Who is it for?
Ages 18 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
BI 764198 - Formula A, BI 764198 - Formula B and BI 764198 - Formula C
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteBelgium
Study dates
15 Jan 2021to 15 Mar 2021
Phase
Phase 1
Are there results?
None posted in the registry

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 50 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
  • 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.

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 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.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • SGS Belgium NV Research Unit Stuivenberg

    Antwerp, 2060

Other trials in Belgium

About this study

Official title: A Two-part Phase I Trial Investigating the Relative Bioavailability and Food Effect of Different Oral Formulations of BI 764198 in Healthy Subjects (an Open-label, Single-dose, Randomised, Crossover Study)

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.

Conditions
Healthy
Being tested
BI 764198 - Formula A, BI 764198 - Formula B, BI 764198 - Formula C, BI 764198 - Formula D

What participants receive

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

  • BI 764198 - Formula ADrug

    Also called Apecotrep

    BI 764198

  • BI 764198 - Formula BDrug

    Also called Apecotrep

    BI 764198

  • BI 764198 - Formula CDrug

    Also called Apecotrep

    BI 764198

  • BI 764198 - Formula DDrug

    Also called Apecotrep

    BI 764198

Study groups in NCT04656288
Study groupRoleWhat they receive
Formula A under fasted conditions - Part 1ExperimentalNot described
Receives: Drug: BI 764198 - Formula A
Formula B under fasted conditions - Part 1ExperimentalNot described
Receives: Drug: BI 764198 - Formula B
Formula B under fasted conditions - Part 2ExperimentalNot described
Receives: Drug: BI 764198 - Formula B
Formula C under fasted conditions - Part 2ExperimentalNot described
Receives: Drug: BI 764198 - Formula C
Formula D under fasted conditions - Part 2ExperimentalNot described
Receives: Drug: BI 764198 - Formula D
Formula B under fed conditions - Part 2ExperimentalNot described
Receives: Drug: BI 764198 - Formula B

What is being measured

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

  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)

    Measured: up to 4 days per period

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

    Measured: 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)

    Measured: up to 5 days per period

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

    Measured: up to 5 days per period

Secondary outcomes (2)

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

    Measured: 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)

    Measured: up to 5 days per period

Timeline

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

  1. First posted7 Dec 2020
  2. Study start15 Jan 2021
  3. Primary completion15 Mar 2021
  4. Study completion15 Mar 2021

Resources

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
Crossover
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04656288
Sponsor's protocol ID
1434-0010
Other IDs
2020-004757-79
Status last verified
Mar 2021
First submitted
1 Dec 2020
Last updated
6 Jul 2026
Results posted
No
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, 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/

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BI 764198 - Formula A, BI 764198 - Formula B and BI 764198 - Formula C in people with Healthy, run by Boehringer Ingelheim at 1 site in Belgium.

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 8 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 6 Jul 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 Belgium. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

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). The study lists 4 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 NCT04656288, 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 6 Jul 2026.

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