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

Launched by BOEHRINGER INGELHEIM · Jul 6, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called BI 1569912 to see how well it is absorbed by the body and how safe it is for healthy Japanese men. The trial will involve giving participants different doses of the medication, both as a single dose and multiple doses over time, to understand how their bodies react to it. The main goal is to ensure that the medication is tolerated well without any serious side effects.

To participate in this study, potential volunteers must be healthy Japanese men aged 18 to 45 years with a normal body weight. They should have no significant health issues and must pass a medical check-up that includes tests for blood pressure, heart rate, and other health indicators. Participants will need to agree to follow certain guidelines to prevent pregnancy during the study. If eligible, participants can expect to receive the medication and be monitored closely for their health and safety throughout the trial. This study is currently active but not recruiting new participants.

Gender

MALE

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
• • History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.