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A Study in Healthy Japanese Men to Test How Well Different Doses of BI 764198 Are Tolerated

NCT ID: NCT04665700

Last Updated: 2021-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-06

Study Completion Date

2021-10-16

Brief Summary

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The main objectives of this trial are to investigate safety and tolerability of BI 764198 in healthy male subjects following oral administration of single dose and multiple rising doses per day over 14 days.

Secondary objectives are the exploration of pharmacokinetics (PK) of BI 764198 after single and multiple oral dosing.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This trial consists of a single dose part and a multiple rising dose (MRD) part. The first dose group is conducted in the single dose part and the second dose group onwards are conducted in the MRD part.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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BI 764198 Single dose part

Group Type EXPERIMENTAL

BI 764198

Intervention Type DRUG

BI 764198

BI 764198 Multiple dose low

Group Type EXPERIMENTAL

BI 764198

Intervention Type DRUG

BI 764198

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

BI 764198 Multiple dose medium

Group Type EXPERIMENTAL

BI 764198

Intervention Type DRUG

BI 764198

BI 764198 Multiple dose high

Group Type EXPERIMENTAL

BI 764198

Intervention Type DRUG

BI 764198

Interventions

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BI 764198

BI 764198

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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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 (BP, PR), 12-lead ECG, and clinical laboratory tests
* Japanese ethnicity, according to the following criteria: born in Japan, have lived outside of Japan \<10 years, and have parents and grandparents who are Japanese
* Age of 20 to 45 years at screening (inclusive)
* BMI of 18.5 to 25.0 kg/m2 (inclusive)
* Signed and dated written informed consent prior to admission to the trial, in accordance with GCP and local legislation
* Willingness to comply with contraception requirements. Subjects who are sexually active must use adequate contraception methods throughout the trial and until three months after the last administration of trial medication. Adequate methods are:

* A vasectomy performed at least 1 year prior to screening and with medical assessment of the surgical success or
* Surgical sterilisation, including bilateral tubal occlusion, hysterectomy or bilateral oophorectomy, of the subject's female partner or
* The use of condoms, if the female partner uses an adequate contraception method in addition, e.g., intrauterine device (IUD), or hormonal contraception, such as implants and injectables\*, combined with oral or vaginal contraceptives, that started at least 2 months prior to first drug administration, or barrier method, e.g., diaphragm with spermicide\* \* hormonal contraception via implants and injectables, and diaphragm with spermicide are not approved in Japan Unprotected sexual intercourse with a pregnant partner is not allowed throughout the trial and until three months after the last administration of trial medication.

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 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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SOUSEIKAI Sumida Hospital

Tokyo, Sumida-ku, , Japan

Site Status

Countries

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Japan

References

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Yonemura T, Sarashina A, Tachibana Y, Retlich S, Soleymanlou N. A randomized, Phase I study of the safety, tolerability, and pharmacokinetics of BI 764198, a transient receptor potential channel 6 (TRPC6) inhibitor, in healthy Japanese men. Expert Opin Investig Drugs. 2025 May;34(5):425-433. doi: 10.1080/13543784.2025.2510664. Epub 2025 Jun 3.

Reference Type DERIVED
PMID: 40402558 (View on PubMed)

Related Links

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http://www.mystudywindow.com

Related Info

Other Identifiers

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1434-0003

Identifier Type: -

Identifier Source: org_study_id