A Study in Healthy Japanese Men to Test How Different Doses of BI 1569912 Are Taken up by the Body and How Well They Are Tolerated

NCT ID: NCT04958252

Last Updated: 2023-10-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-05
• Study Completion Date: 2023-10-24

Brief Summary

The main objectives of this trial are to investigate safety and tolerability of BI 1569912 in healthy male Japanese subjects following oral administration of single rising doses and multiple doses.

Secondary objective is the exploration of pharmacokinetics (PK) of BI 1569912.

Conditions

Healthy

Study Design

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

Study Groups

Part A: BI 1569912 low dose

Group Type: EXPERIMENTAL

BI 1569912

Intervention Type: DRUG

BI 1569912

Part A: BI 1569912 lower medium dose

Group Type: EXPERIMENTAL

BI 1569912

Intervention Type: DRUG

BI 1569912

Part A: BI 1569912 higher medium dose

Group Type: EXPERIMENTAL

BI 1569912

Intervention Type: DRUG

BI 1569912

Part A: BI 1569912 high dose

Group Type: EXPERIMENTAL

BI 1569912

Intervention Type: DRUG

BI 1569912

Part B: BI 1569912 low dose

Group Type: EXPERIMENTAL

BI 1569912

Intervention Type: DRUG

BI 1569912

Part B: BI 1569912 high dose

Group Type: EXPERIMENTAL

BI 1569912

Intervention Type: DRUG

BI 1569912

Part C: BI 1569912

Group Type: EXPERIMENTAL

BI 1569912

Intervention Type: DRUG

BI 1569912

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

BI 1569912

BI 1569912

Intervention Type: DRUG

Placebo

Placebo

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 medical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead Electrocardiogram (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 18 to 45 years (inclusive)
• Body mass index (BMI) of 18.5 to 25.0 kg/m2 (inclusive)
• Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation
• Subjects who agree to minimize the risk of making their partner pregnant by fulfilling any of the following criteria starting from the first administration of trial medication until 90 days after last administration of trial medication

• Use of adequate contraception, any of the following methods plus condom: intrauterine device, combined oral contraceptives that started at least 2 months prior to the first drug administration.
• Vasectomized (vasectomy at least 1 year prior to enrolment)
• Surgical sterilization (including bilateral tubal occlusion, hysterectomy or bilateral oophorectomy) of the subject's female partner

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 40 to 90 mmHg, or pulse rate outside the range of 40 to 99 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: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

SOUSEIKAI Sumida Hospital

Tokyo, Sumida-ku, , Japan

Countries

Japan

Related Links

https://www.mystudywindow.com

Related Info

Other Identifiers

1447-0004

Identifier Type: -

Identifier Source: org_study_id