A Study to Test How Well Healthy Men Tolerate Different Doses of BI 764198

NCT04102462 | Completed Phase 1 FDA Drug

• 2 other identifiers: 1434-00072019-002257-38
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate safety and tolerability of BI 764198 in healthy male subjects following oral administration of multiple rising doses per day over 14 days and to explore the pharmacokinetics (PK) of BI 764198 after single and multiple oral dosing. In addition, the effect of BI 764198 on the pharmacokinetics of midazolam, given as an oral microdose, will be explored after multiple oral dosing.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Percentage of subjects with drug-related adverse events

  Up to Day 34

Secondary Outcomes (5)

• Multiple dose part - AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ)

  Up to Day 34

• Multiple dose part - Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)

  Up to Day 34

• Multiple dose part - tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state)

  Up to Day 34

• Midazolam part - AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

  Up to Day 17

• Midazolam part - Cmax (maximum measured concentration of the analyte in plasma)

  Up to Day 17

Study Arms (2)

Multiple rising dose part

EXPERIMENTAL

Drug: BI 764198; Drug: Matching placebo

Midazolam part

EXPERIMENTAL

Drug: BI 764198; Drug: Matching placebo

Interventions

BI 764198 DRUG

Capsules

Midazolam part; Multiple rising dose part

Matching placebo DRUG

Capsules

Midazolam part; Multiple rising dose part

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
• Age of 18 to 45 years (inclusive)
• BMI of 18.5 to 29.9 kg/m2 (inclusive)
• Signed and dated written informed consent prior to admission to the study, in accordance with GCP and local legislation
• Male subjects who meet any of the following criteria from administration of trial medication until 30 days after trial completion:
• Males who are willing to use a medically acceptable method of contraception. Acceptable methods of contraception for use by male subjects include sexual abstinence, a vasectomy performed at least 1 year prior to dosing, and barrier contraception (condom)
• Subjects who are not vasectomised or sexually abstinent have to ensure that an additional acceptable method of contraception will be used by his female partner such as intrauterine device (IUD), surgical sterilisation (including hysterectomy), hormonal contraception (e.g. implants, injectables, combined oral or vaginal contraceptives) that started at least 2 months prior to drug administration, or barrier method (e.g. diaphragm with spermicide)

You may not qualify if:

• 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 50 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
• Chronic or relevant acute infections
• History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)
• Use of drugs within 30 days or 5 elimination half-lives, of planned administration of trial medication that might reasonably influence the results of the trial (including drugs that cause QT/QTc interval prolongation)
• Intake of an investigational drug in another clinical trial within 60 days or 5 elimination half-lives, of planned administration of investigational drug in the current trial, or concurrent participation in another clinical trial in which investigational drug is administered
• Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)
• Inability to refrain from smoking on specified trial days
• Alcohol abuse (consumption of more 24 g per day)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

CRS Clinical Research Services Mannheim GmbH

Mannheim, 68167, Germany

Location

Related Publications (1)

• 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.

  PMID: 40455255 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: September 25, 2019
• Study Start: October 29, 2019
• Primary Completion: October 8, 2020
• Study Completion: October 8, 2020
• Last Updated: November 4, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)