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

NCT ID: NCT04656288

Last Updated: 2021-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-15
• Study Completion Date: 2021-03-15

Brief 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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Formula A under fasted conditions - Part 1

Group Type: EXPERIMENTAL

BI 764198 - Formula A

Intervention Type: DRUG

BI 764198

Formula B under fasted conditions - Part 1

Group Type: EXPERIMENTAL

BI 764198 - Formula B

Intervention Type: DRUG

BI 764198

Formula B under fasted conditions - Part 2

Group Type: EXPERIMENTAL

BI 764198 - Formula B

Intervention Type: DRUG

BI 764198

Formula C under fasted conditions - Part 2

Group Type: EXPERIMENTAL

BI 764198 - Formula C

Intervention Type: DRUG

BI 764198

Formula D under fasted conditions - Part 2

Group Type: EXPERIMENTAL

BI 764198 - Formula D

Intervention Type: DRUG

BI 764198

Formula B under fed conditions - Part 2

Group Type: EXPERIMENTAL

BI 764198 - Formula B

Intervention Type: DRUG

BI 764198

Interventions

BI 764198 - Formula A

BI 764198

Intervention Type: DRUG

BI 764198 - Formula B

BI 764198

Intervention Type: DRUG

BI 764198 - Formula C

BI 764198

Intervention Type: DRUG

BI 764198 - Formula D

BI 764198

Intervention Type: DRUG

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

SGS Belgium NV Research Unit Stuivenberg

Antwerp, , Belgium

Countries

Belgium

References

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.

Reference Type: DERIVED

PMID: 40455255 (View on PubMed)

Related Links

https://www.mystudywindow.com/

Related Info

Other Identifiers

2020-004757-79

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1434-0010

Identifier Type: -

Identifier Source: org_study_id