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

Boehringer Ingelheim

Status and phase: Active, not recruiting; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: BI 1569912

Study type: Interventional

Funder types: Industry

Identifiers

NCT04958252

1447-0004

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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56 participants in 8 patient groups, including a placebo group

Part A: BI 1569912 low dose

Experimental group

Treatment:

Drug: BI 1569912

Part A: BI 1569912 lower medium dose

Experimental group

Treatment:

Drug: BI 1569912

Part A: BI 1569912 higher medium dose

Experimental group

Treatment:

Drug: BI 1569912

Part A: BI 1569912 high dose

Experimental group

Treatment:

Drug: BI 1569912

Part B: BI 1569912 low dose

Experimental group

Treatment:

Drug: BI 1569912

Part B: BI 1569912 high dose

Experimental group

Treatment:

Drug: BI 1569912

Part C: BI 1569912

Experimental group

Treatment:

Drug: BI 1569912

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo